Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 1025
© 2008 American Society of Clinical Oncology

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Abstract

Capecitabine vs. capecitabine + trastuzumab in patients with HER2-positive metastatic breast cancer progressing during trastuzumab treatment: The TBP phase III study (GBG 26/BIG 3–05)

German Breast Group, Neu-Isenburg, Germany; University Hospital and Cancer Centre, Wien, Austria; Reiner de Graaf Gasthuis, Delft, The Netherlands; Klinik für Gynäkologische Onkologie, Wiesbaden, Germany; University Hospital Mainz, Mainz, Germany; Studienzentrale Gynäkologische Onkologie Universit, Kiel, Germany; Institute of Oncology Ljubljana, Ljubljana, Slovenia; Ikazia Zickenhuis, Rotterdam, The Netherlands; University Hospital Frankfurt, Frankfurt, Germany

1025

Background: There is uncertainty, if trastuzumab treatment should be continued beyond progression (TBP). Methods: Patients (pts) with HER-2 positive, locally advanced or metastatic breast cancer that progressed during treatment with trastuzumab with or without adjuvant and/or 1st-line metastatic chemotherapy were prospectively randomized to capecitabine (X; 2,500 mg/m² on days 1–14, q21) or X plus continuation of trastuzumab (XH; 6 mg/kg, q3w). The primary end point was TTP. With registration of lapatinib, the slowly accruing trial was closed prematurely. Results: Between 01/04 and 05/07 156 pts (X=78; XH=78) were randomized and stratified according to pre-treatment: taxane/trastuzumab as 1st-line therapy (111 pts), taxanes/trastuzumab as adjuvant therapy (3 pts), trastuzumab alone or without taxanes as 1st-line treatment (42 pts). 75 (48.1%) pts were pre-treated with anthracyclines. 119 (76.3%) showed visceral metastasis. Current analysis (median follow-up 11.8 months) revealed a progression-free survival of 5.6 months with 53 events for X and 8.5 months with 48 events for XH (HR=0.71). Brain metastases were observed in 4 (X) and 7 (XH) pts. Overall survival was 19.9 months with 31 events for X and 20.3 months with 26 events in XH (HR=0.79). Crude response rates were 24.6% (X) and 49.1% (XH) and primary progressions were observed in 26.3% (X) and 16% (XH) of patients. Grade III/IV toxicities were (%X/%XH): neutropenia (3.3/6.3), febrile neutropenia (0/0), vomiting (6.0/1.6), diarrhea (20.9/14.8), mucositis (3.0/1.6), hand-foot syndrome (23.9/31.1), nail changes (0/4.9), sensory neuropathy (4.5/3.3), fatigue (6.0/4.9), allergic (3.0/3.3), and cardiac (2.9/4.9). No therapy-related death occurred. Conclusions: Preliminary results of the TBP study suggest a higher efficacy but similar toxicity for continuing trastuzumab beyond trastuzumab progression when 2nd-line chemotherapy with capecitabine is initiated. Final efficacy analysis will be performed in March 2008.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Roche Roche Roche Roche

Abstract presentation from the 2008 ASCO Annual Meeting