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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
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)
G. Von Minckwitz,
C. Zielinski,
E. Maarteense,
P. Vogel,
M. Schmidt,
H. Eidtmann,
T. Cufer,
F. E. de Jongh,
M. Kaufmann and
S. Loibl
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
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Roche |
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Roche |
Roche |
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Roche |
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Abstract presentation from the 2008 ASCO Annual Meeting
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