209 results on '"Harper, Pg"'
Search Results
2. Chemotherapy for ovarian cancer - a consensus statement on standard practice
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Adams, M, Calvert, AH, Carmichael, J, Clark, PI, Coleman, RE, Earl, HM, Gallagher, CJ, Ganesan, TS, Gore, ME, Graham, JD, Harper, PG, Jayson, GC, Kaye, SB, Ledermann, JA, Osborne, RJ, Perren, TJ, Poole, CJ, Radford, JA, Rustin, GJS, Slevin, ML, Smyth, JF, Thomas, H, and Wilkinson, PM more...
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- 1998
- Full Text
- View/download PDF
Catalog
3. ICON2: randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer
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Parmar MKB, Torri V, Bonaventura A, Bonazzi C, Colombo N, Delaloye JF, Marsoni S, Mangioni C, Sandercock J, Sessa C, Williams C, Tinazzi A, Flann M, Geiser K, Scorpiglione N, Stewart JF, Chaves J, Palmeiro E, Curtain A, McCormack T, Gennatas C, Marras F, Oppo TG, Balestrino M, Malzoni C, Malzoni M, Belli M, Geminiani ML, Crestani G, Monaco A, Vavala V, Piatto E, Barattini G, Fornara PG, Chetri MC, Santeufemia G, Artioli F, Carone D, Fanizza G, Trentadue R, Priolo D, Scollo P, Nigro SC, Petrina M, Mastrantonio P, Spanna GD, Zagni R, Belloni C, Colleoni R, Redaelli L, Cavagnini A, Di Costanzo G, Perroni D, Arienti S, Orfanotti G, Cantoni FM, Secli R, Bianchi A, Martinello R, Mollica G, Maizzi D, Picchiarelli ME, Fiorini G, Borsani M, Colombo E, Garsia S, Melgrati L, Paggi G, Brunenghi GM, Casini M, Isa L, Algeri R, Prozio G, Belfiore G, Angelini F, D'Aprile M, Moreschi M, Mauri ML, Natale N, Senzani FM, Pavanato G, Poggi G, Garuti G, Luerti M, Cruciani G, Pagano F, Baccolo M, Poddi ER, Bocciolone L, Sabelli MA, Maggi R, Restelli C, D'Antona A, Locatelli MC, Pessi A, Raina A, Chiari S, Gabriele A, Pittelli MR, Iacobelli P, Dogliotti L, Gorzegno G, Musso P, Vegna G, Coco G, Alletti DG, Picciotto F, Lucchese V, Epis A, di Palumbo VS, Drudi G, Ravaioli A, Zampella D, Morandi MG, Gorga G, Zucchelli C, Cariello S, Galletto L, Sussio M, Massacesi L, Massacesi M, Carli A, Tucci E, Tajani E, Corrado G, Bumma S, Durando A, Massobrio M, Sberveglieri M, Biasio M, Guercio E, Jura R, Danese S, Wierdis T, Farnelli C, Tarantino G, Grassi R, Repetti F, Rocchi B, Grampa M, Ercoli A, Griso C, Signori E, Zanini L, Presti M, Klimek M, Urbanski K, Biswas A, Viegas O, Kochli O, Dreher E, Fey M, Beck G, Ludin J, Bonnefoi H, Krauer F, Bauer J, Delmore G, Furrer C, Lorenz U, Thurlimann B, Bronz L, Sanna P, Wyss D, Goldhirsch A, Gyr T, Leidi L, Pastorelli G, Pagani O, Rey P, Hailer U, Benz J, Kaye SB, Reed NS, Symonds RP, Atkinson RJ, Axford AT, Rustin G, Seckl MJ, Green JA, Scott IV, Guthrie D, Harper PG, Calman F, Dobbs HJ, Weir P, Cassoni A, Lederman JA, Souhami RL, Bozzino J, Adab F, Redman CWE, Scoble JE, Paterson M, Daniel F, Cowley N, Williams CJ, Spooner D, Hong A, McIllmurray M, Hendy-Ibbs P, Hall V, Iveson TJ, Whitehouse JMA, Garry R, Lamont A, Robinson A, Trask CW, Clubb AW, Murrell D, Newman G, Wilkins M, Goldthorp WO, Roberts JK, Radstone DJ, Whipp MJ, Ledermann JA, Pater J, Buyse M, Omura G, Parmar, Mkb, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, Jf, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, Jf, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, Tg, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, Ml, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, Pg, Chetri, Mc, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, Sc, Petrina, M, Mastrantonio, P, Spanna, Gd, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, Fm, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, Me, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, Gm, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, Ml, Natale, N, Senzani, Fm, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, Er, Bocciolone, L, Sabelli, Ma, Maggi, R, Restelli, C, D'Antona, A, Locatelli, Mc, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, Mr, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, Dg, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, Mg, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, Sb, Reed, N, Symonds, Rp, Atkinson, Rj, Axford, At, Rustin, G, Seckl, Mj, Green, Ja, Scott, Iv, Guthrie, D, Harper, Pg, Calman, F, Dobbs, Hj, Weir, P, Cassoni, A, Lederman, Ja, Souhami, Rl, Bozzino, J, Adab, F, Redman, Cwe, Scoble, Je, Paterson, M, Daniel, F, Cowley, N, Williams, Cj, Spooner, D, Hong, A, Mcillmurray, M, Hendy-Ibbs, P, Hall, V, Iveson, Tj, Whitehouse, Jma, Garry, R, Lamont, A, Robinson, A, Trask, Cw, Clubb, Aw, Murrell, D, Newman, G, Wilkins, M, Goldthorp, Wo, Roberts, Jk, Radstone, Dj, Whipp, Mj, Ledermann, Ja, Pater, J, Buyse, M, and Omura, G more...
- Published
- 1998
4. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group
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Aapro, Ms, VAN WIJK FH, Bolis, G, Chevallier, B, VAN DER BURG ME, Poveda, A, Oliveira, Cf, Tumolo, S, SCOTTO DI PALUMBO, V, Piccart, M, Franchi, M, Zanaboni, F, Lacave, Aj, Fontanelli, R, Favalli, G, Zola, Paolo, Guastalla, Jp, Rosso, R, Marth, C, Nooij, M, Presti, M, Scarabelli, C, Splinter, Ta, Ploch, E, Beex, Lv, Ten, Bokkel, Huinink, W, Forni, M, Melpignano, M, Blake, P, Kerbrat, P, Mendiola, C, Cervantes, A, Goupil, A, Harper, Pg, Madronal, C, Namer, M, Scarfone, G, Stoot, Je, Teodorovic, I, Coens, C, Vergote, I, Vermorken, Jb, University of Groningen, and Medical Oncology more...
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Adult ,Male ,medicine.medical_specialty ,Combination therapy ,Health Status ,medicine.medical_treatment ,cisplatin ,endometrial carcinoma ,chemotherapy ,Gastroenterology ,doxorubicin ,CLINICAL-TRIAL ,randomised clinical trial ,SDG 3 - Good Health and Well-being ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,polycyclic compounds ,Humans ,Medicine ,ONCOLOGY-GROUP ,Doxorubicin ,Infusions, Intravenous ,COMBINATION ,Aged ,Gynecology ,Chemotherapy ,Antibiotics, Antineoplastic ,Performance status ,business.industry ,Hazard ratio ,Combination chemotherapy ,ADENOCARCINOMA ,Hematology ,Middle Aged ,1ST-LINE CHEMOTHERAPY ,Prognosis ,Survival Analysis ,phase III ,Endometrial Neoplasms ,Regimen ,Treatment Outcome ,Oncology ,Toxicity ,Female ,business ,PHASE-II TRIAL ,medicine.drug - Abstract
Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group. Background: Combination chemotherapy yields better response rates which do not always lead to a survival advantage. The aim of this study was to investigate whether the reported differences in the efficacy and toxicity of monotherapy with doxorubicin (DOX) versus combination therapy with cisplatin (CDDP) in endometrial adenocarcinoma lead to significant advantage in favour of the combination. Patients and methods: Eligible patients had histologically-proven advanced and/or recurrent endometrial adenocarcinoma and were chemo-naive. Treatment consisted of either DOX 60 mg/m(2) alone or CDDP 50 mg/m(2), added to DOX 60 mg/m(2), every 4 weeks. Results: A total of 177 patients were entered and median follow-up is 7.1 years. The combination DOX-CDDP was more toxic than DOX alone. Haematological toxicity consisted mainly of white blood cell toxicity grade 3 and 4 (55% versus 30%). Non-haematological toxicity consisted mainly of grade 3 and 4 alopecia (72% versus 65%) and nausea/vomiting (36% versus 12%). The combination DOX- CDDP provided a significantly higher response rate than single agent DOX (P more...
- Published
- 2003
5. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: A phase III trial of the gynecologic cancer intergroup
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Bookman, M, Brady, M, Mcguire, W, Harper, P, Alberts, D, Friedlander, M, Colombo, N, Fowler, J, Argenta, P, De Geest, K, Mutch, D, Burger, R, Swart, A, Trimble, E, Accario Winslow, C, Roth, L, Bookman, MA, Brady, MF, McGuire, WP, Harper, PG, Alberts, DS, Fowler, JM, Argenta, PA, Mutch, DG, Burger, RA, Swart, AM, Trimble, EL, Roth, LM, COLOMBO, NICOLETTA, Bookman, M, Brady, M, Mcguire, W, Harper, P, Alberts, D, Friedlander, M, Colombo, N, Fowler, J, Argenta, P, De Geest, K, Mutch, D, Burger, R, Swart, A, Trimble, E, Accario Winslow, C, Roth, L, Bookman, MA, Brady, MF, McGuire, WP, Harper, PG, Alberts, DS, Fowler, JM, Argenta, PA, Mutch, DG, Burger, RA, Swart, AM, Trimble, EL, Roth, LM, and COLOMBO, NICOLETTA more...
- Abstract
PURPOSE: To determine if incorporation of an additional cytotoxic agent improves overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma who receive carboplatin and paclitaxel. PATIENTS AND METHODS: Women with stages III to IV disease were stratified by coordinating center, maximal diameter of residual tumor, and intent for interval cytoreduction and were then randomly assigned among five arms that incorporated gemcitabine, methoxypolyethylene glycosylated liposomal doxorubicin, or topotecan compared with carboplatin and paclitaxel. The primary end point was OS and was determined by pairwise comparison to the reference arm, with a 90% chance of detecting a true hazard ratio of 1.33 that limited type I error to 5% (two-tail) for the four comparisons. RESULTS: Accrual exceeded 1,200 patients per year. An event-triggered interim analysis occurred after 272 events on the reference arm, and the study closed with 4,312 women enrolled. Arms were well balanced for demographic and prognostic factors, and 79% of patients completed eight cycles of therapy. There were no improvements in either PFS or OS associated with any experimental regimen. Survival analyses of groups defined by size of residual disease also failed to show experimental benefit in any subgroup. CONCLUSION: Compared with standard paclitaxel and carboplatin, addition of a third cytotoxic agent provided no benefit in PFS or OS after optimal or suboptimal cytoreduction. Dual-stage, multiarm, phase III trials can efficiently evaluate multiple experimental regimens against a single reference arm. The development of new interventions beyond surgery and conventional platinum-based chemotherapy is required to additionally improve outcomes for women with advanced EOC. more...
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- 2009
6. Paclitaxel and cisplatin in ovarian cancer
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Torri, V, Harper, P, Colombo, N, Sandercock, J, Parmar, M, Harper, PG, Parmar, MK, COLOMBO, NICOLETTA, Torri, V, Harper, P, Colombo, N, Sandercock, J, Parmar, M, Harper, PG, Parmar, MK, and COLOMBO, NICOLETTA more...
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- 2000
7. Preferential location of circulating activated cyclophosphamide within the erythrocyte
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Highley Ms, DeBruijn E, Harper Pg, and Slee Ph
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Cancer Research ,Text mining ,Oncology ,Cyclophosphamide ,business.industry ,Chemistry ,Cancer research ,medicine ,business ,medicine.drug - Published
- 1996
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8. THE TREATMENT OF METASTATIC COLORECTAL CANCER
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Karapetis, CS, primary, Yip, D, additional, and Harper, PG, additional
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- 1999
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9. A randomised trial of low-dose/high-frequency chemotherapy as palliative treatment of poor-prognosis small-cell lung cancer: a Cancer research Campaign trial
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James, LE, primary, Gower, NH, additional, Rudd, RM, additional, Spiro, SG, additional, Harper, PG, additional, Trask, CW, additional, Partridge, M, additional, Ruiz de Elvira, M-C, additional, and Souhami, RL, additional more...
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- 1996
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10. Phase II trial of temozolomide in low-grade non-Hodgkin's lymphoma
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Woll, PJ, primary, Crowther, D, additional, Johnson, PWM, additional, Soukop, M, additional, Harper, PG, additional, Harris, M, additional, Brampton, MH, additional, and Newlands, ES, additional
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- 1995
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11. Protracted oral etoposide in epithelial ovarian cancer: a phase II study in patients with relapsed or platinum-resistant disease
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Seymour, MT, primary, Mansi, JL, additional, Gallagher, CJ, additional, Gore, ME, additional, Harper, PG, additional, Evans, TRJ, additional, Edmonds, PM, additional, and Slevin, ML, additional
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- 1994
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12. High-dose folinic acid with 5-fluorouracil bolus and continuous infusion in the treatment of advanced gastric and oesophageal adenocarcinoma
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Highley, MS, primary, Hill, ME, additional, Ziras, N, additional, Samandas, N, additional, Mason, RC, additional, Owen, W, additional, Dussek, J, additional, Barker, S, additional, and Harper, PG, additional more...
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- 1993
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13. Clinical pharmacokinetics of epirubicin: the importance of liver biochemistry tests
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Twelves, CJ, primary, Dobbs, NA, additional, Michael, Y, additional, Summers, LA, additional, Gregory, W, additional, Harper, PG, additional, Rubens, RD, additional, and Richards, MA, additional
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- 1992
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14. A randomised trial of planned versus as required chemotherapy in small cell lung cancer: a Cancer Research Campaign trial
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Earl, HM, primary, Rudd, RM, additional, Spiro, SG, additional, Ash, CM, additional, James, LE, additional, Law, CS, additional, Tobias, JS, additional, Harper, PG, additional, Geddes, DM, additional, Eraut, D, additional, Partridge, MR, additional, and Souhami, RL, additional more...
- Published
- 1991
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15. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer.
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Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, and Neoptolemos JP more...
- Published
- 2009
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16. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup.
- Author
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Bookman MA, Brady MF, McGuire WP, Harper PG, Alberts DS, Friedlander M, Colombo N, Fowler JM, Argenta PA, De Geest K, Mutch DG, Burger RA, Swart AM, Trimble EL, Accario-Winslow C, Roth LM, Bookman, Michael A, Brady, Mark F, McGuire, William P, and Harper, Peter G more...
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- 2009
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17. The pharmacokinetics of ifosfamide given as short and long intravenous infusions in cancer patients.
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Lewis, LD, primary, Fitzgerald, DL, additional, Mohan, P, additional, Thatcher, N, additional, Harper, PG, additional, and Rogers, HJ, additional
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- 1991
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18. Fractionated ifosfamide therapy produces a time-dependent increase in ifosfamide metabolism.
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Lewis, LD, primary, Fitzgerald, DL, additional, Harper, PG, additional, and Rogers, HJ, additional
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- 1990
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19. The response of cerebral metastases in small cell lung cancer to systemic chemotherapy
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Twelves, CJ, primary, Souhami, RL, additional, Harper, PG, additional, Ash, CM, additional, Spiro, SG, additional, Earl, HM, additional, Tobias, JS, additional, Quinn, H, additional, and Geddes, DM, additional more...
- Published
- 1990
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20. A randomized trial comparing methotrexate and vinblastine (MV) with cisplatin, methotrexate and vinblastine (CMV) in advanced transitional cell carcinoma: results and a report on prognostic factors in a Medical Research Council study. MRC Advanced Bladder Cancer Working Party.
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Mead, GM, Russell, M, Clark, P, Harland, SJ, Harper, PG, Cowan, R, Roberts, JT, Uscinska, BM, Griffiths, GO, Parmar, MKB, Mead, G M, Harland, S J, Harper, P G, Roberts, J T, Uscinska, B M, Griffiths, G O, and Parmar, M K more...
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- 1998
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21. Patients at risk of chemotherapy-associated toxicity in small cell lung cancer.
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Morittu, L, Earl, HM, Souhami, RL, Ash, CM, Tobias, JS, Geddes, DM, Harper, PG, Spiro, SG, Earl, H M, Souhami, R L, Ash, C M, Tobias, J S, Geddes, D M, Harper, P G, and Spiro, S G
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- 1989
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22. Duration of chemotherapy in small cell lung cancer: a Cancer Research Campaign trial.
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Spiro, SG, Souhami, RL, Geddes, DM, Ash, CM, Quinn, H, Harper, PG, Tobias, JS, Partridge, M, and Eraut, D
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- 1989
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23. Pharmacokinetics of idarubicin (4-demethoxydaunorubicin; IMI-30; NSC 256439) following intravenous and oral administration in patients with advanced cancer.
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Gillies, HC, Herriott, D, Liang, R, Ohashi, K, Rogers, HJ, and Harper, PG
- Abstract
The plasma pharmacokinetics of idarubicin (4-demethoxydaunorubicin) were studied in 20 patients with advanced malignant disease after intravenous (21 occasions) and oral (14 occasions) administration. Idarubicin plasma concentrations were measured by high performance liquid chromatography with fluorescence detection. Pharmacokinetic parameters calculated for the intravenous plasma drug concentration, time data revealed a terminal half-life of 12.9 +/- 6.0 h (mean +/- s.d.), clearance 98.7 +/- 47.3 1 h-1 m-2 and volume of distribution 1533 +/- 536 1 m-2. A bi-exponential equation corresponding to a two compartment open model best fitted the data. Half-life and clearance were not significantly different following oral administration. Bioavailability of oral idarubicin was 0.29 +/- 0.20 (mean +/- s.d.). There was a wide range of bioavailability between and within subjects. Plasma concentrations of idarubicinol (the only metabolite detected) rapidly exceeded those of the parent drug, and exposure to this metabolite was greater than to the parent drug. The mean half-life of idarubicinol was not significantly different after i.v. (63.1 +/- 28.2 h) and oral (45.8 +/- 16.0 h) administration. Much larger amounts of this metabolite were formed following the oral route of administration. This may have implications for the clinical use of this drug as idarubicinol may have appreciable cytotoxic activity. [ABSTRACT FROM AUTHOR] more...
- Published
- 1987
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24. Five-day oral etoposide treatment for advanced small-cell lung cancer: randomized comparison with intravenous chemotherapy.
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Souhami RL, Spiro SG, Rudd RM, Ruiz de Elvira MC, James LE, Gower NH, Lamont A, Harper PG, Souhami, R L, Spiro, S G, Rudd, R M, Ruiz de Elvira, M C, James, L E, Gower, N H, Lamont, A, and Harper, P G
- Abstract
Background: Oral etoposide is an active single agent in small-cell lung cancer (SCLC) and is widely prescribed as first-line treatment as an alternative to intravenous combination chemotherapy in patients with extensive disease.Purpose: The intention of this study was to determine if the effects of oral etoposide therapy on survival and quality of life are equivalent to those of intravenous chemotherapy.Methods: In a randomized trial of palliative treatment in advanced SCLC, oral etoposide (100 mg given twice daily for 5 days) was compared with intravenous chemotherapy consisting of alternating cycles of cisplatin and etoposide (PE) and cyclophosphamide, doxorubicin, and vincristine (CAV). Six cycles of chemotherapy were administered every 21 days in both regimens. Symptom control and quality of life were measured with the Rotterdam Symptom Checklist and a daily diary card. In January 1996, after 155 patients had been randomly assigned from a projected intake of 365 patients, an independent Data Monitoring Committee examined the interim results. Survival was determined by the Kaplan-Meier method, and the logrank test was used to compare treatments. For quality-of-life comparisons, average scores were calculated for each time point. The Mann-Whitney U test was used to determine any significant overall differences between treatments. For the Rotterdam Symptom Checklist, separate analyses were done for each subset (psychological well-being, physical symptoms, lung cancer symptoms, treatment symptoms, activity, and quality of life). Response rates and toxicity scores were compared by using chi2. All statistical tests were two-sided.Results: Survival was inferior at 1 year in the oral etoposide group compared with intravenous therapy (9.8% for oral versus 19.3% for intravenous; difference = 9.5%; 95% confidence interval of difference = 0.3%-18.7%; P<.05), and there was a trend toward inferior overall survival. Median survival was 4.8 months for oral treatment and 5.9 months for intravenous therapy. Progression-free survival was worse in the oral etoposide arm (median = 3.6 months versus 5.6 months; P<.001), as well as overall response rate (32.9% versus 46.3%; P<.01). With the exception of acute nausea and vomiting associated with intravenous chemotherapy, all aspects of symptom control and quality of life were either the same or worse in the oral etoposide group. Study closure was recommended.Conclusions: These interim results show that this schedule of oral etoposide is inferior to intravenous chemotherapy in the treatment of advanced SCLC and should not be used as first-line treatment of this disease. [ABSTRACT FROM AUTHOR] more...- Published
- 1997
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25. Spinal cord compression in small cell lung cancer: a retrospective study of 610 patients.
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Goldman, JM, Ash, CM, Souhami, RL, Geddes, DM, Harper, PG, Spiro, SG, and Tobias, JS
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- 1989
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26. A Quality Improvement Project on Team-Based Care for Depression Screening Before and During the COVID-19 Pandemic in a Specialty Clinic.
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Brueggemann AD, Harper PG, Boyer H, Fjestad S, and Burmeister LA
- Abstract
Background: Depression screening is an important first step to identifying patients who might benefit from depression treatment. Merit-based incentive payment system (MIPS) quality measures can yield financial benefits or losses for healthcare systems, including depression screening., Objectives: This study aims to (1) develop a team-based care workflow to improve MIPS depression screening in a specialty clinic and (2) modify the workflow to include a virtual nursing and behavioral health resource after the COVID-19 pandemic hit., Methods: A quality improvement project, utilizing Lean Six Sigma process improvement methods, was implemented to improve team-based depression screening in a specialty clinic. A multidisciplinary team implemented plan-do-study-act cycles, created educational materials tailored to each role, developed electronic medical record (EMR) tools to alert and assist team members in screening, and ensured the EMR aligned with the MIPS criteria. The percentage of eligible visits where depression screening was performed was analyzed across four study periods: pre-intervention, post-intervention, COVID-19, and recovery. Recovery strategies included developing telehealth workflows, establishing centralized registered nurse triage groups, and using phone-based triage and support resources at virtual visits., Results: Utilizing team-based strategy and available or newly developed tools, the percentage of eligible visits with completed depression screening was as follows: 1.4% pre-intervention, 58.2% post-intervention, 3.5% COVID-19, and 64.0% recovery. With the COVID-19 pandemic outbreak, initially, improved screening performance declined sharply. Recovery was achieved through the revision of workflows, team members, and support tools., Conclusions: A team-based care approach can successfully improve and maintain depression screening in a specialty clinic and was versatile enough to be readapted to virtual visits during the COVID-19 pandemic. In addition to impacting MIPS quality incentives, the depression screening workflows described in this article can be adapted to other uses, including virtual and in-person visits and in other specialty or chronic disease settings., Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. University of Minnesota Institutional Review Board issued approval STUDY00016933. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: The Vizient® Transforming Clinical Practice initiative funded by a CMS grant and Advisory Solutions, Operational Effectiveness joined forces to support members through the IMPACT program designed to improve outcomes for patients with diabetes and hypertension. Financial relationships: Alvina Brueggemann declare(s) a grant from Center for Medicaid and Medicare Services administered by Vizient. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Brueggemann et al.) more...
- Published
- 2024
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27. Harmonizing the Tripartite Mission in Academic Family Medicine: A Longitudinal Case Example.
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Peek CJ, Allen M, Loth KA, Harper PG, Martin C, Pacala JT, Buffington A, and Berge JM
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- Humans, Longitudinal Studies, Academic Medical Centers organization & administration, Organizational Case Studies, Organizational Objectives, Family Practice education, Faculty, Medical
- Abstract
Academic practices and departments are defined by a tripartite mission of care, education, and research, conceived as being mutually reinforcing. But in practice, academic faculty have often experienced these 3 missions as competing rather than complementary priorities. This siloed approach has interfered with innovation as a learning health system in which the tripartite missions reinforce each other in practical ways. This paper presents a longitudinal case example of harmonizing academic missions in a large family medicine department so that missions and people interact in mutually beneficial ways to create value for patients, learners, and faculty. We describe specific experiences, implementation, and examples of harmonizing missions as a feasible strategy and culture. "Harmonized" means that no one mission subordinates or drives out the others; each mission informs and strengthens the others (quickly in practice) while faculty experience the triparate mission as a coherent whole faculty job. Because an academic department is a complex system of work and relationships, concepts for leading a complex adaptive system were employed: (1) a "good enough" vision, (2) frequent and productive interactions, and (3) a few simple rules. These helped people harmonize their work without telling them exactly what to do, when, and how. Our goal here is to highlight concrete examples of harmonizing missions as a feasible operating method, suggesting ways it builds a foundation for a learning health system and potentially improving faculty well-being., (© 2024 Annals of Family Medicine, Inc.) more...
- Published
- 2024
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28. Team-based care: an expanded medical assistant role - enhanced rooming and visit assistance.
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Harper PG, Van Riper K, Ramer T, Slattengren A, Adam P, Smithson A, Wicks C, Martin C, Wootten M, Carlson S, Miller E, and Fallert C
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- Humans, Allied Health Personnel, Ambulatory Care Facilities, Primary Health Care, Interprofessional Relations
- Abstract
Primary care practices face significant challenges as they pursue the Quadruple Aim. Redistributing care across the interprofessional primary care team by expanding the role of the medical assistant (MA) is a potential strategy to address these challenges. Two sequential, linked processes to expand the role of the MA, called Enhanced Rooming and Visit Assistance, were implemented in four family medicine residency clinics in Minnesota. In Enhanced Rooming, MAs addressed preventive services, obtained a preliminary visit agenda, and completed a warm hand-off to the provider. In Visit Assistance, MAs stayed in the room the entire visit to assist with the visit workflow. Enhanced Rooming and Visit Assistance processes were successfully implemented and sustained for over one year. MAs and providers were satisfied with both processes, and patients accepted the expanded MA roles. Mammogram ordering rates increased from 10% to 25% (p < 0.0001). After Visit Summary (AVS) print rates increased by 12% (p < 0.0001). Visit Turn-Around-Time (TAT) decreased 3.1 minutes per visit (p = 0.0001). Expanding the MA role in a primary care interprofessional team is feasible and a potentially useful tool to address the Quadruple Aim. more...
- Published
- 2023
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29. Lean Implementation for Graduating Optimally Controlled Stable Type 2 Diabetics from Endocrine Specialty Clinic Back to Primary Care.
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Burmeister LA, Harper PG, Brueggemann A, Adam P, Logeais M, Schechter K, Duncan K, and Boyer H
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- Humans, Ambulatory Care Facilities, Quality Improvement, Primary Health Care, Physicians, Diabetes Mellitus, Type 2 therapy
- Abstract
Introduction: Endocrine specialty clinics (SCs) are occupied by a high percentage of stable follow-up patients, limiting access to new patients with greater needs., Aim: Feasibility project to improve access to diabetes SC by reducing the number of stable optimally controlled follow-up type 2 diabetic patients., Setting: M Health Fairview (MHFV), a hybrid network of University of Minnesota academic and Fairview Health community hospitals and clinics with affiliated providers., Program Description: A team-based lean methodology quality improvement graduation program including medical assistants, nurses, physicians, and a compact with primary care (PC) was used to identify within the Endocrine clinic population the graduation-eligible optimally controlled stable type 2 diabetic patients, acclimate them to the graduation concept, engage in shared decision-making, and transition them back to PC with a warm hand-off and graduation certificate., Program Evaluation: Seventeen percent (58/341) of eligible patients with optimally controlled diabetes graduated by 6 months, ranging between 0 and 83% per week., Discussion: The innovation and feasibility of opening SC access through the use of a team-based graduation program to transfer stable diabetes patients back to their home clinic was demonstrated. This innovation has the potential to support health system triage of new patients to limited access specialty care., (© 2022. The Author(s).) more...
- Published
- 2022
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30. The Nitrogen Mustards.
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Highley MS, Landuyt B, Prenen H, Harper PG, and De Bruijn EA
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- Cyclophosphamide therapeutic use, Humans, Nitrogen therapeutic use, Antineoplastic Agents adverse effects, Neoplasms drug therapy, Nitrogen Mustard Compounds therapeutic use
- Abstract
The nitrogen mustards are powerful cytotoxic and lymphoablative agents and have been used for more than 60 years. They are employed in the treatment of cancers, sarcomas, and hematologic malignancies. Cyclophosphamide, the most versatile of the nitrogen mustards, also has a place in stem cell transplantation and the therapy of autoimmune diseases. Adverse effects caused by the nitrogen mustards on the central nervous system, kidney, heart, bladder, and gonads remain important issues. Advances in analytical techniques have facilitated the investigation of the pharmacokinetics of the nitrogen mustards, especially the oxazaphosphorines, which are prodrugs requiring metabolic activation. Enzymes involved in the metabolism of cyclophosphamide and ifosfamide are very polymorphic, but a greater understanding of the pharmacogenomic influences on their activity has not yet translated into a personalized medicine approach. In addition to damaging DNA, the nitrogen mustards can act through other mechanisms, such as antiangiogenesis and immunomodulation. The immunomodulatory properties of cyclophosphamide are an area of current exploration. In particular, cyclophosphamide decreases the number and activity of regulatory T cells, and the interaction between cyclophosphamide and the intestinal microbiome is now recognized as an important factor. New derivatives of the nitrogen mustards continue to be assessed. Oxazaphosphorine analogs have been synthesized in attempts to both improve efficacy and reduce toxicity, with varying degrees of success. Combinations of the nitrogen mustards with monoclonal antibodies and small-molecule targeted agents are being evaluated. SIGNIFICANCE STATEMENT: The nitrogen mustards are important, well-established therapeutic agents that are used to treat a variety of diseases. Their role is continuing to evolve., (Copyright © 2022 by The Author(s).) more...
- Published
- 2022
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31. Shared Language for Shared Work in Population Health.
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Peek CJ, Westfall JM, Stange KC, Liaw W, Ewigman B, DeVoe JE, Green LA, Polverento ME, Bora N, deGruy FV, Harper PG, and Baker NJ
- Subjects
- Delivery of Health Care, Humans, Public Health, Language, Population Health
- Abstract
People working on behalf of population health, community health, or public health often experience confusion or ambiguity in the meaning of these and other common terms-the similarities and differences and how they bear on the tasks and division of labor for care delivery and public health. Shared language must be clear enough to help, not hinder people working together as they ultimately come to mutual understanding of roles, responsibilities, and actions in their joint work. Based on an iterative lexicon development process, the authors developed and propose a definitional framework as an aid to navigating among related population and community health terms. These terms are defined, similarities and differences clarified, and then organized into 3 categories that reflect goals, realities, and ways to get the job done. Goals include (a) health as well-being for persons, (b) population health as that goal expressed in measurable terms for groups, and (c) community health as population health for particular communities of interest, geography, or other defining characteristic-groups with shared identity and particular systemic influences on health. Realities are social determinants as influences, health disparities as effects, and health equity as both a goal and a design principle. Ways to get the job done include health care delivery systems for enrollees and public health in population-based civic activities-with a broad zone of collaboration where streams of effort converge in partnership with served communities. This map of terms can enable people to move forward together in a broad zone of collaboration for health with less confusion, ambiguity, and conflict., (© 2021 Annals of Family Medicine, Inc.) more...
- Published
- 2021
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32. The Impact of COVID-19 Proactive Outreach With Somali Seniors.
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Reget K, Ali S, Pratt R, and Harper PG
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- Aged, COVID-19 epidemiology, Communication Barriers, Emigrants and Immigrants psychology, Female, Health Services Accessibility statistics & numerical data, Humans, Minnesota, Somalia ethnology, COVID-19 prevention & control, COVID-19 psychology, Needs Assessment statistics & numerical data, Social Isolation psychology, Telephone statistics & numerical data
- Published
- 2021
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33. Team-based approach to improving medication reconciliation rates in family medicine residency clinics.
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Harper PG, Schafer KM, Van Riper K, Justesen K, Ramer T, Wicks C, Oyenuga A, and Budd J
- Subjects
- Ambulatory Care Facilities, Family Practice, Humans, Pharmacists, Internship and Residency, Medication Reconciliation
- Abstract
Objective: The objective of this quality improvement project was to design and implement a systematic team-based care approach to medication reconciliation, with a goal of physician-documented medication reconciliation at 70% of all patient office visits., Setting: Ambulatory clinics located in urban, underserved communities in Minneapolis and St. Paul, MN., Practice Description: Four family medicine residency clinics, with pharmacists integrated at each site. All clinics use the Epic electronic medical record (Epic Systems Corporation)., Practice Innovation: A team-based care approach to medication reconciliation was designed and implemented involving medical assistants (MAs), physicians, and pharmacists. The MAs did an initial review with patients, the physicians addressed discrepancies, and difficult situations were escalated to the pharmacist for a detailed assessment., Evaluation: The percentage of visits with physician-documented medication reconciliation was measured preintervention and then for 18 months postintervention in 6-month intervals involving more than 118,000 patient visits. Satisfaction surveys of team members were done pre- and postintervention., Results: The percentage of visits with physician-documented medication reconciliation improved significantly from 6.5% preintervention to 58.7% (P < 0.001) postintervention, and was sustained and further improved to 70.3% (P < 0.001) 1 year later. The team members had a statistically significant improvement in their ability to articulate the medication reconciliation process. Satisfaction improved significantly for physicians, but MAs did not experience a statistically significant change., Conclusion: A team-based care approach to medication reconciliation was successfully implemented and sustained at 4 family medicine clinics. There was significant improvement in physician-documented medication reconciliation. Future studies need to address whether this process improves medication-list discrepancies, completeness, and accuracy., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.) more...
- Published
- 2021
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34. Financial Impact of Universal Precepting in Family Medicine Residency Clinics.
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Harper PG, Adam P, Wooten M, Smithson A, Martin C, Carlson S, Pattock AM, and Satin DJ
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- Humans, Medically Underserved Area, Minnesota, Administrative Claims, Healthcare economics, Family Practice education, Internship and Residency, Preceptorship economics
- Abstract
Background and Objectives: Precepting methods have significant impact on the financial viability of family medicine residency programs. Following an adverse event, four University of Minnesota Family Medicine residency clinics moved from using Medicare's Primary Care Exception (PCE) and licensure precepting (LP) to a "universal precepting" method in which preceptors see every patient face to face. Variation in the implementation of universal precepting created a natural experiment of its financial impact., Methods: Universal precepting was implemented in October 2013 across four residency programs. Billing codes were measured 1 year before and 2.5 years after implementation by clinic and residency year., Results: There were significant financial differences between clinics based on original precepting method and implementation quality of universal precepting. The clinic moving from PCE to universal precepting with excellent implementation increased higher-level billing (99214) by 8%-10%. Clinics moving from LP demonstrated wide variation ranging from an 18% increase to a 13% decrease, consistent with the implementation quality., Conclusions: Clinics transitioning from PCE to universal precepting can see a significant increase in 99214 billing. Clinics transitioning from LP to universal precepting are at significant financial risk if poorly implemented, but may see increased 99214 billing with effective implementation. This suggests that both implementation quality and original precepting method impact 99214 billing rates when transitioning to universal precepting. more...
- Published
- 2020
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35. Risk of prostate cancer-specific death in men with baseline metabolic aberrations treated with androgen deprivation therapy for biochemical recurrence.
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Rudman SM, Gray KP, Batista JL, Pitt MJ, Giovannucci EL, Harper PG, Loda M, Mucci LA, and Sweeney CJ
- Subjects
- Aged, Aged, 80 and over, Humans, Male, Metabolic Diseases complications, Middle Aged, Neoplasm Recurrence, Local blood, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms complications, Risk Assessment, Androgen Antagonists therapeutic use, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local therapy, Prostatic Neoplasms mortality, Prostatic Neoplasms therapy
- Abstract
Objectives: To investigate the associations of host metabolic factors and metabolic syndrome on prostate cancer-specific death (PCSD) and overall survival (OS) in patients treated with androgen deprivation therapy (ADT) for biochemically recurrent disease., Patients and Methods: The analysis included 273 patients with prostate cancer treated with ADT for rising prostate-specific antigen level after surgery or radiotherapy. Patients were assessed for the presence of diabetes, hypertension, dyslipidaemia and obesity before commencing ADT, and Adult Treatment Panel III criteria were used to assess the presence of the composite diagnosis of metabolic syndrome. A competing risks regression model was used to assess associations of time to PCSD with the metabolic conditions, while a multivariable Cox regression model was used to assess associations of OS with metabolic syndrome and metabolic conditions., Results: During a median follow-up of 11.6 years, 157 patients (58%) died, of whom 58 (21%) died from prostate cancer. At the start of ADT the median (range) patient age was 74 (46-92) years and the median PSA level was 3.0 ng/mL. Metabolic syndrome was observed in 31% of patients; hypertension (68%) and dyslipidaemia (47%) were the most common metabolic conditions. No association of PCSD and metabolic syndrome status was observed. Patients with hypertension tended to have a higher cumulative incidence of PCSD than those without hypertension (sub-distribution hazard ratio [HR] 1.59, 95% confidence interval [CI] 0.89, 2.84; P = 0.11) although the difference was not statistically significant. Patients with metabolic syndrome had an increased risk of death from all causes (HR 1.56, 95% CI 1.07, 2.29; P = 0.02) when compared with patients without metabolic syndrome, as did patients with hypertension (HR 1.72, 95% CI 1.18, 2.49; P = 0.004)., Conclusions: No association of PCSD and metabolic syndrome was observed in this cohort of men receiving ADT for biochemically recurrent prostate cancer. Metabolic syndrome was associated with an increased risk of death from all causes and a similar effect was also observed for patients with prostate cancer with hypertension alone., (© 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.) more...
- Published
- 2016
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36. Community-based participatory research to decrease smoking prevalence in a high-risk young adult population: an evaluation of the Students Against Nicotine and Tobacco Addiction (SANTA) project.
- Author
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Mendenhall TJ, Harper PG, Henn L, Rudser KD, and Schoeller BP
- Subjects
- Adolescent, Demography, Female, Humans, Male, Minnesota epidemiology, Motor Activity, Patient Education as Topic, Prevalence, Program Evaluation, Stress, Psychological epidemiology, Treatment Outcome, Young Adult, Community-Based Participatory Research, Smoking epidemiology, Smoking Prevention
- Abstract
Students Against Nicotine and Tobacco Addiction is a community-based participatory research project that engages local medical and mental health providers in partnership with students, teachers, and administrators at the Minnesota-based Job Corps. This intervention contains multiple and synchronous elements designed to allay the stress that students attribute to smoking, including physical activities, nonphysical activities, purposeful modifications to the campus's environment and rules/policies, and on-site smoking cessation education and peer support. The intent of the present investigation was to evaluate (a) the types of stress most predictive of smoking behavior and/or nicotine dependence, (b) which activities students are participating in, and (c) which activities are most predictive of behavior change (or readiness to change). Quantitative data were collected through 5 campus-wide surveys. Response rates for each survey exceeded 85%. Stressors most commonly cited included struggles to find a job, financial problems, family conflict, lack of privacy or freedom, missing family or being homesick, dealing with Job Corps rules, and other-unspecified. The most popular activities in which students took part were physically active ones. However, activities most predictive of beneficent change were nonphysical. Approximately one third of respondents were nicotine dependent at baseline. Nearly half intended to quit within 1 month and 74% intended to quit within 6 months. Interventions perceived as most helpful toward reducing smoking were nonphysical in nature. Future efforts with this and comparable populations should engage youth in advancing such activities within a broader range of activity choices, alongside conventional education and support. more...
- Published
- 2014
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37. Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial.
- Author
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Eisen T, Joensuu H, Nathan PD, Harper PG, Wojtukiewicz MZ, Nicholson S, Bahl A, Tomczak P, Pyrhonen S, Fife K, Bono P, Boxall J, Wagner A, Jeffers M, Lin T, and Quinn DI
- Subjects
- Aged, Carcinoma, Renal Cell pathology, Female, Humans, Kidney Neoplasms pathology, Male, Middle Aged, Neoplasm Metastasis, Antineoplastic Agents therapeutic use, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy, Phenylurea Compounds therapeutic use, Pyridines therapeutic use
- Abstract
Background: Regorafenib inhibits VEGF receptors 1, 2, and 3 and PDGF receptors like other anti-angiogenic tyrosine-kinase inhibitors approved for treatment of advanced renal-cell cancer. Regorafenib also inhibits other potentially important angiogenic kinases like TIE2, activation of which is thought to be important in tumour escape mechanisms. This phase 2, open-label, non-randomised study assessed the safety and efficacy of the multikinase inhibitor regorafenib for treatment of renal-cell carcinoma., Methods: Patients were recruited from 18 academic oncology centres across Europe and USA. Patients with previously untreated metastatic or unresectable clear-cell renal-cell carcinoma received oral regorafenib (160 mg per day) in repeating cycles of 3 weeks on, 1 week off until disease progression or until patients met the criteria for removal from study. The primary efficacy endpoint was the proportion of patients who achieved an objective overall response, assessed in all patients who were evaluable for response. The trial has finished. This trial is registered with ClinicalTrials.gov, number NCT00664326., Findings: The study was done between April 30, 2008, and June 1, 2011. We screened 64 patients, of whom 49 received regorafenib. Median duration of treatment was 7·1 months (range 0·7-34·4, IQR 2·5-18·0) and at the time of data cutoff, six patients (12%) were still receiving treatment. 48 patients were assessable for tumour response. 19 patients (39·6%, 90% CI 27·7-52·5) had an objective response, all of which were partial responses. Drug-related adverse events occurred in 48 patients (98%) and drug-related serious adverse events in 17 (35%). Grade 3 drug-related adverse events were common, most frequently hand and foot skin reaction (16 patients, 33%), diarrhoea (five patients, 10%), renal failure (five patients, 10%), fatigue (four patients, 8%), and hypertension (three patients, 6%). Two patients had grade 4 treatment-related adverse events: two cardiac ischaemia or infarction, one hypomagnesaemia, and one pain in the chest or thorax. Four patients died during study treatment or within 30 days of last dose, of which two were deemed likely to be related to the study drug., Interpretation: Regorafenib has antitumour activity as first-line treatment for metastatic or unresectable renal-cell carcinoma. The drug's safety profile requires close monitoring., (Copyright © 2012 Elsevier Ltd. All rights reserved.) more...
- Published
- 2012
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38. Efficacy and toxicity of sunitinib in patients with metastatic renal cell carcinoma with severe renal impairment or on haemodialysis.
- Author
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Josephs D, Hutson TE, Cowey CL, Pickering LM, Larkin JM, Gore ME, Van Hemelrijck M, McDermott DF, Powles T, Chowdhury P, Karapetis C, Harper PG, Choueiri TK, and Chowdhury S
- Subjects
- Adult, Aged, Antineoplastic Agents therapeutic use, Carcinoma, Renal Cell pathology, Carcinoma, Renal Cell physiopathology, Disease-Free Survival, Female, Glomerular Filtration Rate, Humans, Indoles therapeutic use, Kidney Failure, Chronic therapy, Kidney Neoplasms physiopathology, Kidney Neoplasms secondary, Male, Middle Aged, Pyrroles therapeutic use, Renal Dialysis, Retrospective Studies, Sunitinib, Treatment Outcome, Antineoplastic Agents adverse effects, Carcinoma, Renal Cell drug therapy, Indoles adverse effects, Kidney Failure, Chronic complications, Kidney Neoplasms drug therapy, Pyrroles adverse effects
- Abstract
Objective: To further investigate the effect of sunitinib, which is currently a standard of care for the treatment of metastatic renal cell carcinoma (mRCC), in patients with severe renal impairment or those undergoing dialysis., Patients and Methods: Clinical databases were used to identify all patients with mRCC treated with sunitinib in seven institutions internationally. Databases were searched to identify only those patients with an estimated glomerular filtration rate of < 30 mL/min/1.73 m² or those who had end-stage renal disease requiring dialysis. Baseline characteristics, adverse event data, response and progression-free survival were recorded., Results: Nineteen patients met the inclusion criteria, 10 of whom were undergoing haemodialysis. Of the nine non-dialysis-dependent patients at drug initiation, the median estimated glomerular filtration rate was 27 mL/min/1.73 m² (range 23-29). Baseline characteristics included a median age of 61 years (range 44-77); 17 patients had a Karnofsky performance status of >80; eight patients had more than two metastatic sites and 17 had undergone prior nephrectomy. The estimated median progression-free survival of this cohort was 43 weeks (range 7 to 158+) and progression has not yet been reached in six patients. Partial response or stable disease was observed as best response in 15 patients. The most common treatment-related adverse events included fatigue, diarrhoea, hand-foot skin reaction (HFSR), nausea and vomiting and rash. Grade three treatment-related adverse events including fatigue (seven patients), HFSR (two patients), diarrhoea (one patient), rash (one patient) and stomatitis (one patient) occurred in a total of 12 patients. Only one patient experienced a grade four adverse event (HFSR). Only diarrhoea (P = 0.0002), HFSR (P < 0.0001) and neutropenia (P = 0.001) were more common in patients undergoing haemodialysis compared with non-dialysis-dependent patients. Four of the non-dialysis dependent patients started at a dose of 50 mg compared with three of the patients undergoing haemodialysis. However five and two of the patients undergoing haemodialysis started at doses of 37.5 mg and 25 mg daily, respectively, compared with four and one of the non-dialysis-dependent patients. All patients took sunitinib for 4 out of every 6 weeks. Dose reductions during treatment were performed in eight patients but only one patient required discontinuation of treatment., Conclusion: These data suggest that patients with severe renal impairment or end-stage renal disease on haemodialysis can be safely treated with sunitinib at doses of 25-50 mg daily for 4 weeks followed by a 2-week break. The observed efficacy of therapy is similar to that reported in patients with normal renal function. These preliminary results warrant confirmation in a larger cohort of patients., (© 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.) more...
- Published
- 2011
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39. A phase I and II trial of epirubicin, cisplatin, 24-hour infusion 5 fluorouracil and sodium folinate in patients with advanced esophagogastric carcinomas.
- Author
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Karapetis CS, Cheong KA, Yip D, Strickland AH, Steer C, Marx G, Yip S, Chrystal K, and Harper PG
- Subjects
- Adenocarcinoma pathology, Aged, Carcinoma, Squamous Cell pathology, Cisplatin administration & dosage, Drug Therapy, Combination, Epirubicin administration & dosage, Esophageal Neoplasms pathology, Female, Follow-Up Studies, Humans, Infusions, Intravenous, Male, Middle Aged, Stomach Neoplasms pathology, Survival Rate, Treatment Outcome, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell drug therapy, Esophageal Neoplasms drug therapy, Leucovorin therapeutic use, Stomach Neoplasms drug therapy, Vitamin B Complex therapeutic use
- Abstract
Aim: Advanced esophagogastric carcinoma has a poor prognosis. Palliative chemotherapy provides a survival advantage and improved quality of life. Epirubicin, cisplatin and continuous infusional 5-fluorouracil (5-FU) (ECF) is a well-established chemotherapy regimen but a continuous chemotherapy infusion is not always feasible or acceptable., Methods: We conducted a phase I and II trial of a modified version of ECF, utilizing 5-FU as a 24-h infusion on day 1 and day 8 of a 21-day cycle, administered with sodium folinate as a modulator of 5-FU (ECSF). In the phase I study the dose of 5-FU was increased in successive cohorts from 1250 mg/m(2) , 1500 mg/m(2) , and 1750 mg/m(2) to 2000 mg/m(2) per 24 h., Results: Dose limiting toxicity of febrile neutropenia was encountered at 2000 mg/m. The recommended dose for 5-FU was 1750 mg/m(2) . Overall 29 patients were treated with ECSF of whom 27 were evaluable for toxicity. The response rate was 45% on an intention-to-treat analysis with a complete response rate of 3%. The median response rate was 4.1 months and the median survival was 10.7 months. A total of 23 patients (72%) obtained clinical benefit with improvement in dysphagia or weight gain. central venous catheter (CVC) complications were observed in 12 (41%) patients., Conclusion: ECSF was associated with a response rate and survival similar to that reported with standard ECF. ECSF may provide an alternative regimen to standard ECF when a continuous ambulatory infusion pump is not feasible or not preferred by the patient. CVC complications are a limitation., (© 2010 Blackwell Publishing Asia Pty Ltd.) more...
- Published
- 2010
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40. Bisphosphonate use in patients with lung cancer and bone metastases: recommendations of a European expert panel.
- Author
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De Marinis F, Eberhardt W, Harper PG, Sureda BM, Nackaerts K, Soerensen JB, Syrigos K, and Trédaniel J
- Subjects
- Bone Neoplasms secondary, Carcinoma, Non-Small-Cell Lung pathology, Humans, Lung Neoplasms pathology, Quality of Life, Retrospective Studies, Bone Neoplasms drug therapy, Carcinoma, Non-Small-Cell Lung drug therapy, Diphosphonates therapeutic use, Lung Neoplasms drug therapy
- Abstract
Introduction: Bisphosphonates (BPs) are effective in preventing, reducing the incidence, and delaying the onset of skeletal-related events in patients with bone metastases in a variety of solid tumors, including lung cancer. The purpose of this article is to review the current evidence for the use of BPs in lung cancer and to provide specific European recommendations to support the clinical practice of using BPs to treat patients with lung cancer with bone metastases., Methods: An expert panel of European clinical oncologists and lung cancer specialists convened for two face-to-face meetings designed to review available evidence on the efficacy of BPs in lung cancer and to develop recommendations based on published literature and clinical practice experiences., Results: The panel recommends screening patients with lung cancer for bone metastases at the initial staging of disease to assess symptomatic bone metastases and screen for asymptomatic bone metastases and to allow accurate monitoring of bone disease progression and initiate bone-specific therapy. Bone assessment should be based on positron emission tomography (if available) or bone scan. BPs should be added to the treatment of patients with lung cancer (with non-small cell lung cancer or small cell lung cancer) who develop bone metastases. In such patients, BPs must be considered part of metastatic lung cancer treatment to prevent and delay the occurrence of further bone metastases and skeletal-related events and to relieve pain where present. BP treatment should continue for as long as it is practically feasible in the absence of any significant adverse effects. more...
- Published
- 2009
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41. A phase II trial of continuous 5-fluorouracil in recurrent or metastatic transitional cell carcinoma of the urinary tract.
- Author
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Highley MS, Griffiths GO, Uscinska BM, Huddart RA, Barber JB, Parmar MK, and Harper PG
- Subjects
- Aged, Antineoplastic Agents adverse effects, Female, Fluorouracil adverse effects, Humans, Male, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local drug therapy, Survival Analysis, Antineoplastic Agents administration & dosage, Carcinoma, Transitional Cell drug therapy, Fluorouracil administration & dosage, Infusion Pumps, Urologic Neoplasms drug therapy
- Abstract
Aims: To assess the activity of a continuous infusion of 5-fluorouracil in patients with recurrent locally advanced or metastatic transitional cell carcinoma of the urinary tract., Materials and Methods: Eight centres within the UK entered 50 patients into the study. Twenty-four weeks of continuously infused 5-fluorouracil, 300mg/m(2)/day through a mini-pump, were planned. The primary outcome was tumour response at 8 weeks after the start of treatment., Results: The median age of the patients was 68 years and 37 (80.4%) had a World Health Organization performance status of 0 or 1. The overall response rate at 8 weeks, according to the response evaluation criteria in solid tumors (RECIST) criteria in 46 evaluable patients, was 15% (95% confidence interval 5-26%) and 20% (95% confidence interval 8-31%) when assessments at all time points were included. The median progression-free survival was 1.9 months (95% confidence interval 1.8-2.7 months) and the median overall survival was 6.5 months (95% confidence interval 4.1-8.5 months). The most frequent grade 3/4 toxicities were mucositis and diarrhoea (each in 6.5% of patients) and nausea/vomiting and hand-foot syndrome (each in 4.3% of patients)., Conclusions: Continuous infusional 5-fluorouracil has activity in transitional cell carcinoma of the urinary tract. Prolonged fluoropyrimidine administration may be a useful component of future combination regimens for this disease, particularly in patients with poor renal function. more...
- Published
- 2009
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42. Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer.
- Author
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Lee SM, James LE, Qian W, Spiro S, Eisen T, Gower NH, Ferry DR, Gilligan D, Harper PG, Prendiville J, Hocking M, and Rudd RM
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin administration & dosage, Carboplatin adverse effects, Cause of Death, Cisplatin administration & dosage, Cisplatin adverse effects, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Etoposide administration & dosage, Etoposide adverse effects, Female, Hospitalization statistics & numerical data, Humans, Lung Neoplasms mortality, Male, Middle Aged, Quality of Life, Small Cell Lung Carcinoma mortality, Treatment Outcome, Gemcitabine, Lung Neoplasms drug therapy, Small Cell Lung Carcinoma drug therapy
- Abstract
Background: The combination of cisplatin and etoposide (PE) has been a standard treatment for patients with poor-prognosis small cell lung cancer (SCLC). This non-inferiority design trial aimed to determine whether the combination of gemcitabine and carboplatin (GC) results in similar survival but is less toxic with better quality of life., Methods: Previously untreated patients with SCLC with extensive disease or limited stage with poor prognostic factors were randomly assigned to six 3-weekly cycles of GC or PE., Results: 241 patients (121 GC, 120 PE) were recruited, of which 216 (90%) had died. There was no difference in overall survival (HR 1.01, 95% CI 0.77 to 1.32). Median survival with GC and PE was 8.0 and 8.1 months, respectively. Median progression-free survival was 5.9 months with GC and 6.3 months with PE. Grade 3 or 4 myelosuppressions were more frequent with GC (anaemia: 14% GC vs 2% PE; leucopenia: 32% GC vs 13% PE; thrombocytopenia: 22% GC vs 4% PE), but these were not associated with increased hospital admissions, infections or fatalities. Grade 2-3 alopecia (68% PE vs 17% GC) and nausea (43% PE vs 26% GC) were more frequent with PE. Patients given GC received more chemotherapy as outpatients (89% GC vs 66% PE of treatment cycles). In QoL questionnaires, more patients receiving PE reported being upset by hair loss (p = 0.004) and impaired cognitive functioning (p = 0.04)., Conclusions: GC is as effective as PE in terms of overall survival and progression-free survival and has a toxicity profile more acceptable to patients., Trial Registration Number: ISRCTN 39679215. more...
- Published
- 2009
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43. The role of cytoreductive nephrectomy for renal cell carcinoma in the era of targeted therapy.
- Author
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Chowdhury S, Harper PG, and Choueiri TK
- Subjects
- Carcinoma, Renal Cell drug therapy, Humans, Immunotherapy, Interferons therapeutic use, Interleukin-2 therapeutic use, Kidney Neoplasms drug therapy, Nephrectomy methods, Carcinoma, Renal Cell surgery, Kidney Neoplasms surgery
- Published
- 2008
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44. A Randomized Study of Electronic Diary versus Paper and Pencil Collection of Patient-Reported Outcomes in Patients with Non-Small Cell Lung Cancer.
- Author
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Ring AE, Cheong KA, Watkins CL, Meddis D, Cella D, and Harper PG
- Abstract
Background: Hand-held electronic devices may provide a simple reproducible means by which quality of life (QOL) may be documented in patients with cancer. However, the QOL scales that are routinely used were originally validated when used with paper and pencil data collection. Patient-reported outcomes acquired using hand-held electronic devices (electronic patient-reported outcomes [e-PRO]) may not be the same as those acquired using paper and pencil, so validation of this method of data collection is needed., Objectives: This study aimed to compare the results of e-PRO and paper and pencil collection of Functional Assessment of Cancer Therapy-Lung (FACT-L) and EuroQol-5 Dimension (EQ-5D) QOL data in patients with advanced non-small cell lung cancer (NSCLC), and to ascertain patients' preferences for the different modes of collection., Methods: This randomized, single-cohort, crossover study was performed in a tertiary referral hospital cancer center. Fifty patients with previously treated locally advanced or metastatic NSCLC were randomized in a 1 : 1 ratio to complete either paper versions of the questionnaires (FACT-L and EQ-5D) followed by the e-PRO versions, or the e-PRO questionnaire followed by the paper versions., Results: The majority (88%) of the FACT-L and all (100%) of the EQ-5D individual question responses were within ±1 point of each other when data collection via e-PRO and via pencil and paper were compared. There was no significant difference between the mean total FACT-L scores obtained using the two methods; however, 29% of patients had a difference between FACT-L total scores obtained with the two methods that was greater than ±6 points. The mean completion time was shorter for the paper and pencil method than the e-PRO method (p < 0.0001). However, most patients stated that they preferred the e-PRO method over paper and pencil (60% vs 12%)., Conclusion: This study suggests that the mode of administration of the FACT-L and EQ-5D had a relatively small effect on the mean responses given to the questionnaires in patients with advanced NSCLC. However, at the individual patient level, data varied considerably between the different modes of administration. Therefore, the group results obtained using the e-PRO should be similar to the originally validated paper method, with the advantages of improved patient acceptability and ease of reliable interfacing with trial databases. more...
- Published
- 2008
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45. Chemotherapy for the treatment of hormone-refractory prostate cancer.
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Chowdhury S, Burbridge S, and Harper PG
- Subjects
- Humans, Male, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Neoplasms, Hormone-Dependent drug therapy, Prostatic Neoplasms drug therapy
- Abstract
Aims: This review aims at analysing the published literature on chemotherapy for hormone-refractory prostate cancer (HRPC) to provide recommendations for the treatment of this important patient group., Methods: The information for this review was compiled using the PubMed and Medline databases and the Proceedings of the American Society of Clinical Oncology annual meetings to search for articles, abstracts and presentations up to 1 March 2007. Electronic early-release publications were also included. Only articles published in English were considered. The search terms included hormone-refractory prostate cancer, docetaxel, mitoxantrone, satraplatin, ixabepilone, cyclophosphamide, vinorelbine, atrasentan, calcitriol, bevacizumab and targeted therapies. Priority was given to studies in high impact factor journals when available., Results and Conclusion: Two recent trials (TAX 327 and SWOG 9916) have shown that docetaxel chemotherapy can significantly improve survival for HRPC. Docetaxel has become the standard of care for first-line chemotherapy for HRPC and has been approved for use in the United States and Europe. Many patients with HRPC will require second- and even third-line treatment upon progression and more data are required in this setting. It is likely that the future management of patients with HRPC will build on the success of docetaxel using a sequence of chemotherapy and targeted therapies to reduce the risk of death, prevent or improve disease-related symptoms and improve quality of life for this important condition. more...
- Published
- 2007
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46. Adjuvant chemotherapy in non-small cell lung cancer.
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Cheong KA, Chrystal K, and Harper PG
- Subjects
- Administration, Oral, Chemotherapy, Adjuvant, Humans, Antineoplastic Agents administration & dosage, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy
- Abstract
Adjuvant chemotherapy is considered a standard of care for many malignancies, the most well known being breast and colon cancer. Unfortunately, less than a third of patients with non-small cell lung cancer (NSCLC) present with resectable disease and despite resection outcomes are often poor with a median 5-year survival of 40-50%. Modern chemotherapy for NSCLC provides both a survival advantage and an improvement in quality of life in the palliative setting. Several large studies using modern platinum-based regimens have been presented since the 1995 meta-analysis. This demonstrated a nonsignificant benefit for older platinum-based regiments. These studies have consistently shown a survival benefit across all stages of resection with acceptable toxicity. The absolute magnitude of benefit is consistent with that achieved in other malignancies where adjuvant chemotherapy is offered as a standard of care. more...
- Published
- 2007
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47. Neoadjuvant chemotherapy for locally advanced carcinoma of the lower oesophagus and oesophago-gastric junction.
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Forshaw MJ, Gossage JA, Chrystal K, Cheong K, Atkinson S, Botha A, Harper PG, and Mason RC
- Subjects
- Adenocarcinoma drug therapy, Adenocarcinoma surgery, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell surgery, Cisplatin administration & dosage, Epirubicin administration & dosage, Esophageal Neoplasms mortality, Esophageal Neoplasms surgery, Female, Fluorouracil administration & dosage, Humans, Male, Middle Aged, Stomach Neoplasms mortality, Stomach Neoplasms surgery, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Esophageal Neoplasms drug therapy, Esophagogastric Junction, Neoadjuvant Therapy, Stomach Neoplasms drug therapy
- Abstract
Aims: To evaluate a single unit's experience with neoadjuvant chemotherapy for treating locally advanced non-metastatic initially resectable and unresectable oesophago-gastric cancer., Methods: The medical records of all patients with either locally advanced carcinoma of the lower oesophagus or cardia treated with neoadjuvant chemotherapy between August 1999 and January 2003 were reviewed., Results: Sixty-four patients with initially resectable tumours (T2-3 or N+) and 38 patients with initially unresectable tumours (T4 or M1a) received neoadjuvant chemotherapy (83% combination Epirubicin, Cisplatin and 5-Fluorouracil). Symptomatic grade III/IV toxicity was observed in 33% of patients. Chemotherapy was not completed in 20 patients because of death (5.9%) and inadequate tumour response/toxicity (13.7%). Forty-three patients (67.3%) with initially resectable tumours and 19 patients (50%) with initially unresectable tumours underwent surgery., Conclusions: Chemotherapy in this study was associated with appreciable toxicity. Patients with initially unresectable locally advanced disease can be downstaged with neoadjuvant chemotherapy. more...
- Published
- 2006
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48. Vinorelbine: friend or foe?
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Robertson JH, Dixit A, Smith A, and Harper PG
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- Abdominal Pain, Bone Neoplasms drug therapy, Bone Neoplasms secondary, Disease Progression, Female, Humans, Liver Neoplasms drug therapy, Liver Neoplasms secondary, Middle Aged, Neoplasm Metastasis, Vinblastine adverse effects, Vinorelbine, Antineoplastic Agents, Phytogenic adverse effects, Breast Neoplasms drug therapy, Carcinoma drug therapy, Vinblastine analogs & derivatives
- Published
- 2006
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49. The management of PS2 patients with advanced non-small cell lung cancer.
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Cheong KA, Chrystal K, and Harper PG
- Subjects
- Carcinoma, Non-Small-Cell Lung pathology, Humans, Lung Neoplasms pathology, Neoplasm Staging, Quality of Life, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Severity of Illness Index
- Abstract
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related deaths in the Western world. Patients with impaired performance status (PS2 or greater) have both worse prognosis and toxicity from treatment in general. The median survival of PS2 patients with advanced NSCLC is 4-5 months in comparison with the 8-9 months expected for those with good performance status (PS0-1). PS2 represents 30%-40% of all patients with advanced NSCLC, and their management remains controversial. In general, they have been excluded from most clinical trials. The emphasis on treatment should be on maintenance and improvement of quality of life with treatment strategies that provide rapid clinical improvement. more...
- Published
- 2006
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50. Gemcitabine and oxaliplatin followed by paclitaxel and carboplatin as first line therapy for patients with suboptimally debulked, advanced epithelial ovarian cancer. A phase II trial of sequential doublets. The GO-First Study.
- Author
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Steer CB, Chrystal K, Cheong KA, Galani E, Marx GM, Strickland AH, Yip D, Lofts F, Gallagher C, Thomas H, and Harper PG
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carboplatin administration & dosage, Carboplatin adverse effects, Combined Modality Therapy, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Drug Administration Schedule, Female, Humans, Middle Aged, Organoplatinum Compounds administration & dosage, Organoplatinum Compounds adverse effects, Ovarian Neoplasms surgery, Oxaliplatin, Paclitaxel administration & dosage, Paclitaxel adverse effects, Survival Rate, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Ovarian Neoplasms drug therapy
- Abstract
Objectives: Gemcitabine and oxaliplatin are active in epithelial ovarian cancer with minimal overlapping toxicity. We studied the efficacy and toxicity of this combination in patients with advanced ovarian cancer when given prior to carboplatin and paclitaxel., Methods: Chemonaive patients with epithelial ovarian cancer and measurable disease were eligible for the study. Treatment consisted of gemcitabine 1250 mg/m2 on days 1 and 8 and oxaliplatin 130 mg/m2 on day 8 every 21 days (GO) for 4 cycles. This was followed by carboplatin AUC = 6 and paclitaxel 175 mg/m2 on day 1 every 21 days (CP) for 4 cycles., Results: Twenty patients, median age 62 years (range 39-78), FIGO stages III (16) and IV (4) received treatment. The response rate (RR) after 4 cycles of GO was 80% (95%CI 61-99%) (4 complete responses (CR), 12 partial responses (PR)). Interval debulking surgery was performed in 7 patients (35%). After CP chemotherapy, RR increased to 85% (95%CI 68-100%) (CR = 13, PR = 4). Median time to progression was 14.5 months. Estimated median overall survival was 31.5 months. Toxicities of GO were mild; grade 3/4 nausea in 3 patients (15%) and vomiting in 2 patients (10%), grade 3/4 neutropenia in 5 patients (25%). Grade 2/3 peripheral neuropathy occurred in 5 patients (25%). After sequential administration of CP, grade 2/3 neuropathy occurred in 13 patients (72%)., Conclusion: The sequential doublet regimen of GO followed by CP resulted in unacceptable neurotoxicity and is not recommended for further study; however, the doublet gemcitabine and oxaliplatin has significant activity in the first line treatment of patients with ovarian cancer. more...
- Published
- 2006
- Full Text
- View/download PDF
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