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572 results on '"Gelber R. D."'

1. Tailoring the optimal duration of the extended adjuvant endocrine therapy in patients with early-stage breast cancer. A systematic review and meta-analysis of randomized clinical trials

Author

Pala, L, De Pas, T, Pagan, E, Sala, I, Catania, C, Zattarin, E, Arnone, P, Grassi, M, Colleoni, M, Wolff, A, Cortes, J, Piccart, M, Gelber, R, Viale, G, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Sala I., Catania C., Zattarin E., Arnone P., Grassi M. M., Colleoni M., Wolff A. C., Cortes J., Piccart M., Gelber R. D., Viale G., Bagnardi V., Conforti F., Pala, L, De Pas, T, Pagan, E, Sala, I, Catania, C, Zattarin, E, Arnone, P, Grassi, M, Colleoni, M, Wolff, A, Cortes, J, Piccart, M, Gelber, R, Viale, G, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Sala I., Catania C., Zattarin E., Arnone P., Grassi M. M., Colleoni M., Wolff A. C., Cortes J., Piccart M., Gelber R. D., Viale G., Bagnardi V., and Conforti F.

Abstract

Background: Controversy exists regarding the optimal duration of the extended adjuvant endocrine treatment (ET) in patients with early-stage breast-cancer (eBC). We performed a systematic review and trial-level meta-analysis of all randomized clinical trials (RCTs) comparing a “limited-extended” adjuvant ET (defined as more than 5 but less than 7.5 years of treatment overall) versus a “full-extended” adjuvant ET (defined as more than 7.5 years of treatment overall) in eBC. Methods: To be eligible, RCTs had to i) compare a “limited-extended” adjuvant ET versus a “full-extended” adjuvant ET in patients with eBC; and ii) report disease-free survival (DFS) hazard ratio (HR) according to the disease nodal-status [i.e., nodal-negative (N-ve) versus nodal-positive (N + ve)]. The primary endpoint was to assess the difference in efficacy of full-versus limited-extended ET, measured in terms of the difference in DFS log-HR, according to the disease nodal-status. Secondary endpoint was the difference in efficacy of full-versus limited-extended ET according to tumor size (i.e., pT1 vs pT2/3/4), histological grade (i.e., G1/G2 vs G3), patients’ age (i.e., ≤60 vs > 60 years) and previous type of ET (i.e., aromatase inhibitors vs tamoxifen vs switch strategy). Results: Three phase III RCTs fulfilled the inclusion criteria. A total of 6689 patients were included in the analysis, of which 3506 (53%) had N + ve disease. The full-extended ET provided no DFS-benefit as compared with the limited-extended ET in patients with N-ve disease (pooled DFS-HR = 1.04, 95%CI: 0.89 to 1.22; I2 = 18%). Conversely, in patients with N + ve disease the full-extended ET significantly improved DFS, with a pooled DFS-HR of 0.85 (95%CI: 0.74 to 0.97; I2 = 0%). There was a significant interaction between the disease nodal-status and the efficacy of the full-versus limited-extended ET (p-heterogeneity = 0.048). The full-extended ET provided no significant DFS-benefit as compared with the limited-extended

Published
2023

2. Improved outcomes in women with BRAF-mutant melanoma treated with BRAF/MEK-targeted therapy across randomized clinical trials. A systematic review and meta-analysis

Author

Pala, L, De Pas, T, Pagan, E, Minucci, S, Catania, C, Digiacomo, N, Cocorocchio, E, Laszlo, D, Di Muzio, A, Barigazzi, C, Stucchi, E, De Grandi, L, Stucchi, S, Viale, G, Gelber, R, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Minucci S., Catania C., Digiacomo N., Cocorocchio E., Laszlo D., Di Muzio A., Barigazzi C., Stucchi E., De Grandi L., Stucchi S., Viale G., Gelber R. D., Bagnardi V., Conforti F., Pala, L, De Pas, T, Pagan, E, Minucci, S, Catania, C, Digiacomo, N, Cocorocchio, E, Laszlo, D, Di Muzio, A, Barigazzi, C, Stucchi, E, De Grandi, L, Stucchi, S, Viale, G, Gelber, R, Bagnardi, V, Conforti, F, Pala L., De Pas T., Pagan E., Minucci S., Catania C., Digiacomo N., Cocorocchio E., Laszlo D., Di Muzio A., Barigazzi C., Stucchi E., De Grandi L., Stucchi S., Viale G., Gelber R. D., Bagnardi V., and Conforti F.

Abstract

Available evidence suggests that in patients with advanced BRAF V600-mutant melanoma treated with the combination of BRAF and MEK inhibitors, gender could be associated with survival outcome. We performed a systematic review and meta-analysis of all randomized clinical trials (RCTs) testing the combination of BRAF and MEK inhibitors, to assess the interaction between treatment effect and patients’ gender. We searched PubMed, MEDLINE, Embase, and Scopus, for phase II and III RCTs up to January 30, 2022. We included all RCTs that enrolled patients with BRAF V600-mutant advanced cutaneous melanoma and assessed combinations of BRAF and MEK inhibitors versus BRAF inhibitor monotherapy. Our aim was to assess differences if any in treatment efficacy between men and women, measured in terms of the differences in progression-free survival (PFS) and overall survival (OS) log-hazard ratios (log-HRs). We calculated the pooled PFS- and OS-HRs with 95% confidence intervals (CIs) in men and women using a random-effects model and assessed the heterogeneity between the estimates using an interaction test. Five RCTs that enrolled a total of 2,113 patients were included in the analysis. In women, the combination of BRAF and MEK inhibitors halved the risk of progression or death as compared with BRAF inhibitor monotherapy with a pooled PFS-HR of 0.50 (95%CI 0.41–0.61). In men, the benefit obtained with BRAF and MEK inhibitors was smaller with a pooled PFS-HR of 0.63 (95%CI 0.54–0.74), P-heterogeneity = .05. A similar trend was observed for OS where the pooled OS-HR was 0.62 (95%CI 0.48–0.80) in women and only 0.78, (95%CI 0.67–0.92) in men, P-heterogeneity = 0.11. These results support meaningful gender-based heterogeneity of response to combination of BRAF and MEK inhibitors targeted therapy in patients with advanced BRAF-mutant melanoma, that should be considered in future research to improve treatment effectiveness.

Published
2023

3. Overall survival in the OlympiA phase Ill trial of adjuvant olaparib in patients with germime pathogenic variants in BRCA1/2 and high-risk, early breast cancer

Author

Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., Johannsson, O. Th, Geyer, C. E., Jr., Garber, J. E., Gelber, R. D., Yothers, G., Taboada, M., Ross, L., Rastogi, P., Cui, K., Arahmani, A., Aktan, G., Armstrong, A. C., Arnedos, M., Balmana, J., Bergh, J., Bliss, J., Delaloge, S., Domchek, S. M., Eisen, A., Elsafy, F., Fein, L. E., Fielding, A., Ford, J. M., Friedman, S., Gelmon, K. A., Gianni, L., Gnant, M., Hollingsworth, S. J., Im, S-A, Jager, A., Lakhani, S. R., Janni, W., Linderholm, B., Liu, T-W, Loman, N., Korde, L., Loibl, S., Lucas, P. C., Marme, F., de Duenas, E. Martinez, McConnell, R., Phillips, K-A, Piccart, M., Rossi, G., Schmutzler, R., Senkus, E., Shao, Z., Sharma, P., Singer, C. F., Spanic, T., Stickeler, E., Toi, M., Traina, T. A., Viale, G., Zoppoli, G., Park, Y. H., Yerushalmi, R., Yang, H., Pang, D., Jung, K. H., Mailliez, A., Fan, Z., Tennevet, I, Zhang, J., Nagy, T., Sonke, G. S., Sun, Q., Parton, M., Colleoni, M. A., Schmidt, M., Brufsky, A. M., Razaq, W., Kaufman, B., Cameron, D., Campbell, C., Tutt, A. N. J., and Johannsson, O. Th

Abstract

Background: The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. Patients and methods: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. Results: With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Delta 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Delta 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Delta 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. Conclusion: With 35 years of median follow-up, OlympiA demonstrates statistical

Published
2022

4. Impact of statin use on survival outcomes of patients with HER2-positive early breast cancer in the APHINITY trial

Author

Maurer, C., Agostinetto, E., Ameye, L., Lambertini, M., Martel, S., Ponde, N. F., Brandao, M., Poggio, F., Ferreira, A. R., Schiff, R., De Angelis, C., Gelber, R. D., Dent, S., Thomssen, C., Piccart, M., de Azambuja, E., Maurer, C., Agostinetto, E., Ameye, L., Lambertini, M., Martel, S., Ponde, N. F., Brandao, M., Poggio, F., Ferreira, A. R., Schiff, R., De Angelis, C., Gelber, R. D., Dent, S., Thomssen, C., Piccart, M., and de Azambuja, E.

Published
2022

5. Subpopulation Treatment Effect Pattern Plot (STEPP) Methods with R and Stata

Author

Venturini, Sergio, Bonetti, M., Lazar, A. A., Cole, B. F., Wang, X., Gelber, R. D., Yip, W., Venturini S. (ORCID:0000-0002-6574-3337), Venturini, Sergio, Bonetti, M., Lazar, A. A., Cole, B. F., Wang, X., Gelber, R. D., Yip, W., and Venturini S. (ORCID:0000-0002-6574-3337)

Abstract

We introduce the stepp packages for R and Stata that implement the subpopulation treatment effect pattern plot (STEPP) method. STEPP is a nonparametric graphical tool aimed at examining possible heterogeneous treatment effects in subpopulations defined on a continuous covariate or composite score. More pecifically, STEPP considers overlapping subpopulations defined with respect to a continuous covariate (or risk index) and it estimates a treatment effect for each subpopulation. It also produces confidence regions and tests for treatment effect heterogeneity among the subpopulations. The original method has been extended in different directions such as different survival contexts, outcome types, or more efficient procedures for identifying the overlapping subpopulations. In this paper, we also introduce a novel method to determine the number of subjects within the subpopulations by minimizing the variability of the sizes of the subpopulations generated by a specific parameter combination. We illustrate the packages using both synthetic data and publicly available data sets. The most intensive computations in R are implemented in Fortran, while the Stata version exploits the powerful Mata language.

Published
2022

6. Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT

Author

Regan, M. M., Walley, B. A., Francis, P. A., Fleming, G. F., Láng, I., Gómez, H. L., Colleoni, M., Tondini, C., Pinotti, G., Salim, M., Spazzapan, S., Parmar, V., Ruhstaller, T., Abdi, E. A., Gelber, R. D., Coates, A. S., Goldhirsch, A., and Pagani, O.

Published
2017
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7. Quality of Life Assessment in the Adjuvant Setting: Is It Relevant?

Author

Gelber, R. D., Bonetti, M., Cole, B. F., Gelber, S., Goldhirsch, A., Schlag, P. M., editor, Senn, H.-J., editor, Diehl, V., editor, Parkin, D. M., editor, Rajewsky, M. F., editor, Rubens, R., editor, Wannenmacher, M., editor, Senn, Hans-Jörg, editor, Gelber, Richard D., editor, Goldhirsch, Aron, editor, and Thürlimann, Beat, editor

Published
1998
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8. Adjuvant Systemic Therapy: The Issues of Timing and Sequence

Author

Castiglione-Gertsch, M., Gelber, R. D., Goldhirsch, A., Herfarth, Ch., editor, Senn, H. J., editor, Baum, M., editor, Diehl, V., editor, Gutzwiller, F., editor, Rajewsky, M. F., editor, Wannenmacher, M., editor, Senn, Hans Jörg, editor, Gelber, Richard D., editor, Goldhirsch, Aron, editor, and Thürlimann, Beat, editor

Published
1996
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9. Summary

Author

Goldhirsch, A., Wood, W. C., Senn, H. J., Glick, J. H., Gelber, R. D., Herfarth, Ch., editor, Senn, H. J., editor, Baum, M., editor, Diehl, V., editor, Gutzwiller, F., editor, Rajewsky, M. F., editor, Wannenmacher, M., editor, Senn, Hans Jörg, editor, Gelber, Richard D., editor, Goldhirsch, Aron, editor, and Thürlimann, Beat, editor

Published
1996
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10. Symptoms of endocrine treatment and outcome in the BIG 1-98 study

Author

Huober, J., Cole, B. F., Rabaglio, M., Giobbie-Hurder, A., Wu, J., Ejlertsen, B., Bonnefoi, H., Forbes, J. F., Neven, P., Láng, I., Smith, I., Wardley, A., Price, K. N., Goldhirsch, A., Coates, A. S., Colleoni, M., Gelber, R. D., Thürlimann, B., and for the BIG 1-98 Collaborative and International Breast Cancer Study Groups

Published
2014
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11. Adjuvant Therapy of Primary Breast Cancer: Closing Summary

Author

Glick, J. H., Gelber, R. D., Goldhirsch, A., Senn, H.-J., Herfarth, Ch., editor, Senn, H.-J., editor, Baum, M., editor, Diehl, V., editor, Gutzwiller, F., editor, Rajewsky, M. F., editor, Wannenmacher, M., editor, Senn, Hans-Jörg, editor, Gelber, Richard D., editor, Goldhirsch, Aron, editor, and Thürlimann, Beat, editor

Published
1993
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13. How To Compare Quality of Life of Breast Cancer Patients in Clinical Trials

Author

for the International Breast Cancer Study Group, Bern, Switzerland, Gelber, R. D., Cole, B. F., Goldhirsch, A., Herfarth, Ch., editor, Senn, H.-J., editor, Baum, M., editor, Diehl, V., editor, Gutzwiller, F., editor, Rajewsky, M. F., editor, Wannenmacher, M., editor, Senn, Hans-Jörg, editor, Gelber, Richard D., editor, Goldhirsch, Aron, editor, and Thürlimann, Beat, editor

Published
1993
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24. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013

Author

Goldhirsch, A., Winer, E. P., Coates, A. S., Gelber, R. D., Piccart-Gebhart, M., Thürlimann, B., Senn, H.-J., Albain, Kathy S., André, Fabrice, Bergh, Jonas, Bonnefoi, Hervé, Bretel-Morales, Denisse, Burstein, Harold, Cardoso, Fatima, Castiglione-Gertsch, Monica, Coates, Alan S., Colleoni, Marco, Costa, Alberto, Curigliano, Giuseppe, Davidson, Nancy E., Di Leo, Angelo, Ejlertsen, Bent, Forbes, John F., Gelber, Richard D., Gnant, Michael, Goldhirsch, Aron, Goodwin, Pamela, Goss, Paul E., Harris, Jay R., Hayes, Daniel F., Hudis, Clifford A., Ingle, James N., Jassem, Jacek, Jiang, Zefei, Karlsson, Per, Loibl, Sibylle, Morrow, Monica, Namer, Moise, Kent Osborne, C., Partridge, Ann H., Penault-Llorca, Frédérique, Perou, Charles M., Piccart-Gebhart, Martine J., Pritchard, Kathleen I., Rutgers, Emiel J.T., Sedlmayer, Felix, Semiglazov, Vladimir, Shao, Zhi-Ming, Smith, Ian, Thürlimann, Beat, Toi, Masakazu, Tutt, Andrew, Untch, Michael, Viale, Giuseppe, Watanabe, Toru, Wilcken, Nicholas, Winer, Eric P., and Wood, William C.

Published
2013
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25. Overall survival benefit for sequential doxorubicin–docetaxel compared with concurrent doxorubicin and docetaxel in node-positive breast cancer—8-year results of the Breast International Group 02-98 phase III trial†

Author

Oakman, C., Francis, P. A., Crown, J., Quinaux, E., Buyse, M., De Azambuja, E., Margeli Vila, M., Andersson, M., Nordenskjöld, B., Jakesz, R., Thürlimann, B., Gutiérrez, J., Harvey, V., Punzalan, L., DellʼOrto, P., Larsimont, D., Steinberg, I., Gelber, R. D., Piccart-Gebhart, M., Viale, G., and Di Leo, A.

Published
2013
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30. Long-term results of International Breast Cancer Study Group Trial VIII: adjuvant chemotherapy plus goserelin compared with either therapy alone for premenopausal patients with node-negative breast cancer

Author

Karlsson, P., Sun, Z., Braun, D., Price, K. N., Castiglione-Gertsch, M., Rabaglio, M., Gelber, R. D., Crivellari, D., Collins, J., Murray, E., Zaman, K., Colleoni, M., Gusterson, B. A., Viale, G., Regan, M. M., Coates, A. S., and Goldhirsch, A.

Published
2011
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33. Adverse prognostic value of peritumoral vascular invasion: is it abrogated by adequate endocrine adjuvant therapy? Results from two International Breast Cancer Study Group randomized trials of chemoendocrine adjuvant therapy for early breast cancer

Author

Viale, G., Giobbie-Hurder, A., Gusterson, B. A., Maiorano, E., Mastropasqua, M. G., Sonzogni, A., Mallon, E., Colleoni, M., Castiglione-Gertsch, M., Regan, M. M., Price, K. N., Brown, R. W., Golouh, R., Crivellari, D., Karlsson, P., Öhlschlegel, C., Gelber, R. D., Goldhirsch, A., and Coates, A. S.

Published
2010

41. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial

Author

Untch, M., Gelber, R. D., Jackisch, C., Procter, M., Baselga, J., Bell, R., Cameron, D., Bari, M., Smith, I., Leyland-Jones, B., de Azambuja, E., Wermuth, P., Khasanov, R., Feng-yi, F., Constantin, C., Mayordomo, J. I., Su, C.-H., Yu, S.-Y., Lluch, A., Senkus-Konefka, E., Price, C., Haslbauer, F., Sahui, T. Suarez, Srimuninnimit, V., Colleoni, M., Coates, A. S., Piccart-Gebhart, M. J., and Goldhirsch, A.

Published
2008

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