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14. SYSTEMIC TREATMENT OF EARLY BREAST-CANCER BY HORMONAL, CYTOTOXIC, OR IMMUNE THERAPY - 133 RANDOMIZED TRIALS INVOLVING 31000 RECURRENCES AND 24000 DEATHS AMONG 75000 WOMEN .2

Author

ABE, O, ABE, R, ASAISHI, K, ENOMOTO, K, HATTORI, T, INO, Y, KIKUCHI, K, KOYAMA, H, SAWA, K, UCHINO, J, YOSHIDA, M, HAYBITTLE, J, VANDEVELDE, T, VERMORKEN, J, HARVEY, V, HOLDAWAY, T, KAY, R, MASON, B, FORBES, J, BASTERT, G, SAUERBREI, W, SCHEURLEN, H, SCHUMACHER, M, FOCAN, C, LOBELLE, J, PEEK, U, OATES, G, POWELL, J, DURAND, M, MAURIAC, L, GELMAN, R, HENDERSON, I, SHAPIRO, C, HANCOCK, A, JACKSON, S, RAGAZ, J, KORZUN, A, WOOD, W, YOSHIMOTO, M, BAUM, M, HOUGHTON, J, HORGAN, K, HUGHES, L, STEWART, H, GORDON, N, DAVIS, H, DELOZIER, T, MACELESECH, J, RAMBERT, P, ANDRYSEK, O, BARKMANOVA, J, OWEN, J, HOWELL, A, RIBEIRO, G, SWINDELL, R, DEOLIVEIRA, C, CARSTENSEN, B, PALSHOF, T, JOHANSEN, H, KORZENIOWSKI, S, SKOLYSZEWSKI, J, ANDERSEN, K, DOMBERNOWSKY, P, MOURIDSEN, H, ROSE, C, CORCORAN, N, TRAMPISCH, H, ABELOFF, M, CARBONE, P, GLICK, J, GRAY, R, TORMEY, D, BUYSE, M, MIGNOLET, F, PARIDAENS, R, VANDRIEL, O, SYLVESTER, R, VANDEVELDE, C, VANDONGEN, J, WELVAART, K, SCANLON, E, SCHURMAN, S, CATALANO, R, CREECH, R, DESCHRYVER, A, MCGREGOR, K, YOSEF, H, MCARDLE, C, SMITH, D, LARA, P, DENT, D, GUDGEON, C, HACKING, A, BOCCARDO, F, IZUO, M, BENTLEY, A, DORAN, Z, FENTIMAN, I, HAYWARD, J, RUBENS, R, KAUFMANN, M, JONAT, W, VONFOURNIER, D, KLEFSTROM, P, CUZICK, J, MARGREITER, R, ASSELAIN, B, POUILLARD, P, BAHI, J, MILLA, A, SANCHIZ, F, CASTIGLIONE, M, CAVALLI, F, COLLINS, J, GELBER, R, GOLDHIRSCH, A, ISLEY, M, LINDTNER, J, PRICE, K, RUDENSTAM, C, SENN, H, BLISS, J, CHILVERS, C, COOMBES, R, MARTY, M, BOROVIK, R, BRUFMAN, G, ROBINSON, E, PANNUTI, F, TAKASHIMA, S, YASUTOMI, T, HOLM, L, SONOO, H, YAMASHITA, J, BONTE, J, BUZDAR, A, SMITH, T, MARTIN, P, ROMAIN, S, AHMANN, D, SCHAID, D, HAKES, T, NORTON, L, WITTES, R, FOROGLOU, P, LISSAIOS, B, BONADONNA, G, DELVECCHIO, M, VALAGUSSA, P, VERONESI, U, DUBOIS, J, HAYAT, H, BIANCO, A, LIPPMAN, M, PIERCE, L, SIMON, R, STEINBERG, S, NOMURA, Y, DELAHUERTA, R, SAINZ, M, BROWN, A, FISHER, B, REDMOND, C, WOLMARK, N, JACKSON, I, PALMER, M, INGLE, J, BENGTSSON, N, LARSSON, L, LYTHGOE, J, KISSIN, M, BLAMEY, R, MITCHELL, A, ROBERTSON, J, FLUCKIGER, H, NAKAMURA, Y, MATHE, G, MISSET, J, DESHPANDE, N, DIMARTINO, L, CLARKE, E, MCLAUGHLIN, J, CLARK, R, LEVINE, M, MORIMOTO, K, GUNDERSEN, S, HAUERJENSEN, M, HOST, H, CROSSLEY, E, DURRANT, K, HARRIS, A, CLARKE, M, COLLINS, R, GODWIN, J, GREAVES, E, HARWOOD, C, MEAD, G, PETO, R, WHEATLEY, K, HILL, C, LACOUR, J, LAPLANCHE, A, LE, M, SARRAZIN, D, SEMIGLAZOV, V, BROCKSCHMIDT, J, COOPER, M, MEAKIN, J, PANZARELLA, T, PRITCHARD, K, TREURNIETDONKER, A, VANPUTTEN, W, EASTON, D, POWLES, T, GAZET, J, DOUGLAS, P, LINDTNER, A, NOTTER, G, BRYANT, A, EWING, G, KRUSHEN, J, NISSENMEYER, R, FORREST, A, MCDONALD, C, MOLLER, T, RYDEN, S, CARSTENSEN, J, HATSCHEK, T, SODERBERG, M, CARPENTER, J, CRAWLEY, J, GREEN, S, OSBORNE, C, RUTQVIST, L, WALLGREN, A, BRENNER, H, HERCBERGS, A, DEBOER, G, PATERSON, A, NAJA, A, REID, M, SPITTLE, M, SENANAYAKE, F, MEIER, P, TENGRUP, I, TENNVALLNITTBY, L, CAFFIER, H, BEZWODA, W, HOLMBERG, L, SEVELDA, P, ZIELINSKY, C, JAKESZ, R, BUCHANAN, R, CROSS, M, DUNN, J, GILLESPIE, KELLY, K, MORRISON, J, LITTON, A, and CHLEBOWSKI, R

Published
1992

20. A randomized comparison of cyclophosphamide, Adriamycin, and 5-fluorouracil with triethylenethiophosphoramide and methotrexate, both as sequential and as fixed rotational treatment in patients with advanced ovarian cancer.

Author

Bruckner, Howard W., Dinse, Gregg E., Davis, Thomas E., Falkson, Geoffrey, Creech, Richard H., Arseneau, James C., Greenspan, Ezra M., Brodovsky, Harvey S., Pagano, Marcello, Hahn, Richard G., Bruckner, H W, Dinse, G E, Davis, T E, Falkson, G, Creech, R H, Arseneau, J C, Greenspan, E M, Brodovsky, H S, Pagano, M, and Hahn, R G

Published
1985
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30. Exaggerated radiation-induced fibrosis in patients with systemic sclerosis.

Author

Varga, J, Haustein, U F, Creech, R H, Dwyer, J P, and Jimenez, S A

Subjects
COMPARATIVE studies, RESEARCH methodology, MEDICAL cooperation, RADIATION doses, RADIOTHERAPY, RESEARCH, SKIN, EVALUATION research, FIBROSIS
Abstract

Four patients with stable systemic sclerosis and limited skin involvement received radiation for the treatment of solid malignant neoplasms. Following localized irradiation, each patient developed an exaggerated cutaneous and internal fibrotic reaction in the irradiated areas. The surface area of fibrosis extended beyond the radiation portals employed, and the fibrotic process was poorly responsive to antifibrotic therapy. Three of the patients died of complications caused by fibrous encasement of internal organs. The extent and severity of postradiation fibrosis in these patients was distinctly unusual. These observations suggest that patients with systemic sclerosis are particularly susceptible to developing excessive radiation-induced fibrosis. [ABSTRACT FROM AUTHOR]

Published
1991
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31. A comparative clinical trial of adriamycin and 5-fluorouracil in advanced prostatic cancer: Prognostic factors and response

Author

Janardan D. Khandekar, William D. Dewys, Colin B. Begg, Creech R, and Harvey S. Brodovsky

Subjects
Male, Oncology, medicine.medical_specialty, Urology, medicine.medical_treatment, Acid Phosphatase, Adenocarcinoma, law.invention, Randomized controlled trial, law, Prostate, Internal medicine, medicine, Humans, Clinical Trials as Topic, Chemotherapy, business.industry, Prostatic Neoplasms, Cancer, Prognosis, medicine.disease, Clinical trial, medicine.anatomical_structure, Doxorubicin, Fluorouracil, Hormone therapy, business, medicine.drug
Abstract

In patients with metastatic hormone-relapsed adenocarcinoma of the prostate, adriamycin was compared to 5-fluorouracil in a randomized trial in 99 patients and adriamycin alone was studied in an open trial in 48 patients. Response to adriamycin was superior as judged by response of measurable disease (25 vs 8%; P less than 0.05) and survival (median 29 vs 24 weeks; Cox analysis, P less than 0.03), but comparable as judged by acid phosphatase response. Ambulatory status and site of metastases influenced rate of response to chemotherapy. Activity level, site of metastases, weight loss, and the symptom of protein aversion were prognostic factors for survival. Hematologic and gastrointestinal toxicity were frequent but were tolerated satisfactorily. Adriamycin therapy may be beneficial in patients with prostatic cancer after hormone therapy.

Published
1983
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32. A randomized comparison of cyclophosphamide, adriamycin, and 5-fluorouracil with triethylenethiophosphoramide and methotrexate, both as sequential and as fixed rotational treatment in patients with advanced ovarian cancer

Author

Richard G. Hahn, Thomas E. Davis, Howard W. Bruckner, Creech R, Geoffrey Falkson, Ezra M. Greenspan, Gregg E. Dinse, Harvey S. Brodovsky, James C. Arseneau, and Marcello Pagano

Subjects
Cancer Research, medicine.medical_specialty, Percentile, Hysterectomy, Performance status, Cyclophosphamide, business.industry, medicine.medical_treatment, Urology, Evaluable Disease, Surgery, Oncology, Fluorouracil, Ambulatory, medicine, Methotrexate, business, medicine.drug
Abstract

The combinations of triethylenethiophosphoramide and methotrexate (TM) and cyclophosphamide, Adriamycin (doxorubicin), and 5-fluorouracil (CAF) were compared, both as sequential and fixed rotational treatments for advanced ovarian cancer, with L-phenylalanine mustard (L-PAM). Treatment with CAF produced a higher response rate (25% complete responses plus 31% partial responses) than treatment with L-PAM (15% complete responses plus 18% partial responses). A fixed rotation of TM and CAF resulted in longer survival (median of 15 months and 75th percentile of 27 months) than sequential treatment with TM initially, followed by CAF upon failure (median of 12 months and 75th percentile of 22 months). The fixed rotation of TM and CAF also increased progression-free survival (median of 12 months and 75th percentile of 24 months) over that achieved by initial treatment with TM (median of 6 months and 75th percentile of 15 months) or L-PAM (median of 9 months and 75th percentile of 21 months). Most patients (96%) on the fixed rotation were treated with both TM and CAF. Fewer patients (62%) on the sequential schedule with TM actually received both combination regimens, and even fewer patients (37%) beginning on CAF ever crossed over to TM. Patient age of 50 years or younger was a favorable prognostic factor for response, survival, and time to first treatment failure (progression-free survival). Disease Stage IIIA or IIIB, surgery including a bilateral salpingo-oophorectomy plus hysterectomy, and treatment within 6 months of initial diagnosis were favorable predictors for both survival and time to first treatment failure. Ambulatory performance status and well-differentiated disease were favorable prognostic factors for survival. Patients with unevaluable disease failed later than those with evaluable disease who, in turn, failed later than patients with measurable disease.

Published
1985
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33. Genotypic‐Environmental Interactions for Sweet Corn Hybrids Produced by the Conventional and Cytoplasmic‐Genetic Male Sterile Methods1

Author

Creech, R. G., Synder, R. J., Wann, E. V., and Lachman, W. H.

Abstract

Genotypic‐environmental interactions were ascertained for 13 plant and ear characters of importance in sweet corn (Zea maysL.). The experiment consisted of 14 hybrids evaluated at each of 5 locations for 3 consecutive years. The results suggest the manner in which each character should be evaluated. In addition, comparisons were made between hybrids produced by the conventional method and hybrids produced by the cyto‐sterile method. The differences between the two types for most economic characters were insignificant

Published
1968
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34. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials

Author

Abe, O., Abe, R., Enomoto, K., Kikuchi, K., Koyama, H., Masuda, H., Nomura, Y., Sakai, K., Sugimachi, K., Tominaga, T., Uchino, J., Yoshida, M., Haybittle, J. L., Davies, C., Harvey, V. J., Holdaway, T. M., Kay, R. G., Mason, B. H., Forbes, J. F., Wilcken, N., Gnant, M., Jakesz, R., Ploner, M., Yosef, H. M. A., Focan, C., Lobelle, J. P., Peek, U., Oates, G. D., Powell, J., Durand, M., Mauriac, L., Di Leo, A., Dolci, S., Piccart, M. J., Masood, M. B., Parker, D., Price, J. J., Hupperets, P. S. G. J., Jackson, S., Ragaz, J., Berry, D., Broadwater, G., Cirrincione, C., Muss, H., Norton, L., Weiss, R. B., Abu-Zahra, H. T., Portnoj, S. M., Baum, M., Cuzick, J., Houghton, J., Riley, D., Mansel, R. E., Gordon, N. H., Davis, H. L., Beatrice, A., Mihura, J., Naja, A., Lehingue, Y., Romestaing, P., Dubois, J. B., Delozier, T., Mace Lesec'h, J., Rambert, P., Petruzelka, L., Pribylova, O., Owen, J. R., Harbeck, N., Jänicke, F., Meisner, C., Meier, P., Howell, A., Ribeiro, G. C., Swindell, R., Burrett, J., Clarke, M., Collins, R., Darby, S., Elphinstone, P., Evans, V., Godwin, J., Gray, R., Harwood, C., Hicks, C., Jackson, D., James, S., Mackinnon, E., Mcgale, P., Mchugh, T., Mead, G., Morris, P., Oulds, J., Peto, R., Taylor, C., Wang, Y., Albano, J., De Oliveira, C. F., Gervásio, H., Gordilho, J., Johansen, H., Mouridsen, H. T., Gelman, R. S., Harris, J. R., Henderson, I. C., Shapiro, C. L., Christiansen, P., Ejlertsen, B., Møller, S., Overgaard, M., Carstensen, B., Palshof, T., Trampisch, H. J., Dalesio, O., De Vries, E. G. E., Rodenhuis, S., Van Tinteren, H., Comis, R. L., Davidson, N. E., Robert, N., Sledge, G., Tormey, D. C., Wood, W., Cameron, D., Chetty, U., Forrest, P., Jack, W., Rossbach, J., Klijn, J. G. M., Treurniet-Donker, A. D., Van Putten, W. L. J., Costa, A., Veronesi, U., Bartelink, H., Duchateau, L., Legrand, C., Sylvester, R., Van Der Hage, J. A., Van De Velde, C. J. H., Cunningham, M. P., Catalano, R., Creech, R. H., Bonneterre, J., Fargeot, P., Fumoleau, P., Kerbrat, P., Namer, M., Jonat, W., Kaufmann, M., Schumacher, M., Von Minckwitz, G., Bastert, G., Rauschecker, H., Sauer, R., Sauerbrei, W., Schauer, A., De Schryver, A., Vakaet, L., Belfiglio, M., Nicolucci, A., Pellegrini, F., Sacco, M., Valentini, M., Mcardle, C. S., Smith, D. C., Galligioni, E., Boccardo, F., Rubagotti, A., Dent, D. M., Gudgeon, C. A., Hacking, A., Erazo, A., Medina, J. Y., Izuo, M., Morishita, Y., Takei, H., Fentiman, I. S., Hayward, J. L., Rubens, R. D., Skilton, D., Scheurlen, H., Von Fournier, D., Dafni, U., Fountzilas, G., Klefstrom, P., Blomqvist, C., Saarto, T., Margreiter, R., Asselain, B., Salmon, R. J., Vilcoq, J. R., Arriagada, R., Hill, C., Laplanche, A., M. G., Lê, Spielmann, M., Bruzzi, P., Montanaro, E., Rosso, R., Sertoli, M. R., Venturini, M., Amadori, D., Benraadt, J., Kooi, M., Van De Velde, A. O., Van Dongen, J. A., Vermorken, J. B., Castiglione, M., Cavalli, F., Coates, A., Collins, J., Forbes, J., Gelber, R. D., Goldhirsch, A., Lindtner, J., Price, K. N., Rudenstam, C. M., Senn, H. J., Bliss, J. M., Chilvers, C. E. D., Coombes, R. C., Hall, E., Marty, M., Borovik, R., Brufman, G., Hayat, H., Robinson, E., Wigler, N., Bonadonna, G., Camerini, T., De Palo, G., Del Vecchio, M., Formelli, F., Valagussa, P., Martoni, A., Pannuti, F., Cocconi, G., Colozza, A., Camisa, R., Aogi, K., Takashima, S., Ikeda, T., Inokuchi, K., Sawa, K., Sonoo, H., Korzeniowski, S., Skolyszewski, J., Ogawa, M., Yamashita, J., Bonte, J., Christiaens, R., Paridaens, R., Van Den Bogaert, W., Martin, P., Geniez, ROMAIN SYLVAIN JEAN, Hakes, T., Hudis, C. A., Wittes, R., Giokas, G., Kondylis, D., Lissaios, B., De La Huerta, R., Sainz, M. G., Altemus, R., Cowan, K., Danforth, D., Lichter, A., Lippman, M., O'Shaughnessy, J., Pierce, L. J., Steinberg, S., Venzon, D., Zujewski, J. A., Paradiso, A., De Lena, M., Schittulli, F., Myles, J. D., Pater, J. L., Pritchard, K. I., Whelan, T., Anderson, S., Bass, G., Brown, A., Bryant, J., Costantino, J., Dignam, J., Fisher, B., Redmond, C., Wieand, S., Wolmark, N., Jackson, I. M., Palmer, M. K., Ingle, J. N., Suman, V. J., Bengtsson, N. O., Jonsson, H., Larsson, L. G., Lythgoe, J. P., Kissin, M., Erikstein, B., Hannisdal, E., Jacobsen, A. B., Varhaug, J. E., Gundersen, S., Hauer-Jensen, M., Høst, H., Nissen-Meyer, R., Blamey, R. W., Mitchell, A. K., Morgan, D. A. L., Robertson, J. F. R., Di Palma, M., Mathé, G., Misset, J. L., Clark, R. M., Levine, M., Morimoto, K., Takatsuka, Y., Crossley, E., Harris, A., Talbot, D., Taylor, M., Di Blasio, B., Ivanov, V., Semiglazov, V., Brockschmidt, J., Cooper, M. R., Ueo, H., Falkson, C. I., A'Hern, R., Ashley, S., Powles, T. J., Smith, I. E., Yarnold, J. R., Gazet, J. C., Corcoran, N., Deshpande, N., Di Martino, L., Douglas, P., Lindtner, A., Notter, G., Bryant, A. J. S., Ewing, G. H., Firth, L. A., Krushen-Kosloski, J. L., Foster, L., George, W. D., Stewart, H. J., Stroner, P., Malmström, P., Möller, T. R., Rydén, S., Tengrup, I., Tennvall-Nittby, L., Carstenssen, J., Dufmats, M., Hatschek, T., Nordenskjöld, B., Söderberg, M., Carpenter, J. T., Albain, K., Crowley, J., Green, S., Martino, S., Osborne, C. K., Ravdin, P. M., Glas, U., Johansson, U., Rutqvist, L. E., Singnomklao, T., Wallgren, A., Maibach, R., Thürlimann, B., Brenner, H., Hercbergs, A., Yoshimoto, M., Deboer, G., Paterson, A. H. G., Meakin, J. W., Panzarella, T., Shan, Y., Shao, Y. F., Wang, X., Zhao, D. B., Chen, Z. M., Pan, H. C., Bahi, J., Reid, M., Spittle, M., Deutsch, G. P., Senanayake, F., Kwong, D. L. W., Bianco, A. R., Carlomagno, C., De Laurentiis, M., De Placido, S., Buzdar, A. U., Smith, T., Bergh, J., Holmberg, L., Liljegren, G., Nilsson, J., Seifert, M., Sevelda, P., Zielinsky, C. C., Buchanan, R. B., Cross, M., Royle, G. T., Dunn, J. A., Hills, R. K., Lee, M., Morrison, J. M., Spooner, D., Litton, A., Chlebowski, R. T., Caffier, H., Clarke, M, Collins, R, Darby, S, Davies, C, Elphinstone, P, Evans, E, Godwin, J, Gray, R, Hicks, C, James, S, MacKinnon, E, McGale, P, McHugh, T, Peto, R, Taylor, C, and Wang, Y

Subjects
medicine.medical_specialty, Time Factors, medicine.medical_treatment, Breast Neoplasms, Rate ratio, Breast Conservation Treatment, Disease-Free Survival, Breast cancer, Cause of Death, Breast-conserving surgery, Medicine, Humans, Lung cancer, Aged, Probability, Randomized Controlled Trials as Topic, business.industry, Female, Middle Aged, Neoplasm Recurrence, Local, Medicine (all), General Medicine, medicine.disease, Surgery, Radiation therapy, Unilateral Breast Neoplasms, Neoplasm Recurrence, Local, business, Mastectomy
Abstract

Background In early breast cancer, variations in local treatment that substantially affect the risk of locoregional recurrence could also affect long-term breast cancer mortality. To examine this relationship, collaborative meta-analyses were undertaken, based on individual patient data, of the relevant randomised trials that began by 1995. Methods Information was available on 42 000 women in 78 randomised treatment comparisons (radiotherapy vs no radiotherapy, 23 500; more vs less surgery, 9300; more surgery vs radiotherapy, 9300). 24 types of local treatment comparison were identified. To help relate the effect on local (ie, locoregional) recurrence to that on breast cancer mortality, these were grouped according to whether or not the 5-year local recurrence risk exceeded 10% (10%, 25 000 women). Findings About three-quarters of the eventual local recurrence risk occurred during the first 5 years. In the comparisons that involved little (10%) differences, however, 5-year local recurrence risks were 7% active versus 26% control (absolute reduction 19%), and 15-year breast cancer mortality risks were 44·6% versus 49·5% (absolute reduction 5·0%, SE 0·8, 2p These 25 000 women included 7300 with breast-conserving surgery (BCS) in trials of radiotherapy (generally just to the conserved breast), with 5-year local recurrence risks (mainly in the conserved breast, as most had axillary clearance and node-negative disease) 7% versus 26% (reduction 19%), and 15-year breast cancer mortality risks 30·5% versus 35·9% (reduction 5·4%, SE 1·7, 2p=0·0002; overall mortality reduction 5·3%, SE 1·8, 2p=0·005). They also included 8500 with mastectomy, axillary clearance, and node-positive disease in trials of radiotherapy (generally to the chest wall and regional lymph nodes), with similar absolute gains from radiotherapy; 5-year local recurrence risks (mainly at these sites) 6% versus 23% (reduction 17%), and 15-year breast cancer mortality risks 54·7% versus 60·1% (reduction 5·4%, SE 1·3, 2p=0·0002; overall mortality reduction 4·4%, SE 1·2, 2p=0·0009). Radiotherapy produced similar proportional reductions in local recurrence in all women (irrespective of age or tumour characteristics) and in all major trials of radiotherapy versus not (recent or older; with or without systemic therapy), so large absolute reductions in local recurrence were seen only if the control risk was large. To help assess the life-threatening side-effects of radiotherapy, the trials of radiotherapy versus not were combined with those of radiotherapy versus more surgery. There was, at least with some of the older radiotherapy regimens, a significant excess incidence of contralateral breast cancer (rate ratio 1·18, SE 0·06, 2p=0·002) and a significant excess of non-breast-cancer mortality in irradiated women (rate ratio 1·12, SE 0·04, 2p=0·001). Both were slight during the first 5 years, but continued after year 15. The excess mortality was mainly from heart disease (rate ratio 1·27, SE 0·07, 2p=0·0001) and lung cancer (rate ratio 1·78, SE 0·22, 2p=0·0004). Interpretation In these trials, avoidance of a local recurrence in the conserved breast after BCS and avoidance of a local recurrence elsewhere (eg, the chest wall or regional nodes) after mastectomy were of comparable relevance to 15-year breast cancer mortality. Differences in local treatment that substantially affect local recurrence rates would, in the hypothetical absence of any other causes of death, avoid about one breast cancer death over the next 15 years for every four local recurrences avoided, and should reduce 15-year overall mortality.

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