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• W4235322571 abstract "842 Background: The safety profile of weekly H is well known. However, recent studies have shown that H 6mg/kg q3w is as well tolerated and maintains therapeutic H levels over 21 days. Based on these data, we have investigated H q3w plus docetaxel (T), vinorelbine (N) or capecitabine (X). Methods: 31 patients (pts) with HER2-positive (23 IHC 3+, 8 IHC2+/FISH-positive) disease were enrolled. 20 pts were treated first line (prior adjuvant chemotherapy allowed). 11 patients had received prior therapy for RBC (1–3 regimens). Drug doses: H–8mg/kg loading, 6mg/kg q3w, day (d)1; T–100mg/m2, d1; N–25mg/m2, d1/8; X–2500 mg/m2, d1–14. Treatment was discontinued or cytotoxic changed upon disease progression. Results: H was combined with T, N or X in 11, 11 and 12 patients respectively. A total of 293 courses have been given (range 3–30, median 9.45). In 2 pts, N replaced X and in one pt X replaced N upon progression. In one pt, T was given after X and N. 2 pts received H/T plus carboplatin and one received H/N plus gemcitabine. In 2 IHC2+/FISH-positive pts, treatment was discontinued after FISH reassessment (these pts were included in the toxicity evaluation). Overall, the q3w H-containing regimens were well tolerated. The majority of toxicities observed were typical of the cytotoxics administered. Five pts displayed H infusion-related reactions. One H/X pt with previous anthracycline exposure displayed a grade 2 decrease in LVEF, associated with an intraventricular clot and persistant hypokalaemia. H, but not X, was discontinued and LVEF normalised 6 months later. One H/T pt with known lymhangitic pulmonary disease had transient post-infusion dyspnea. Although, given the heterogeneity of the study, efficacy of the q3w schedule cannot be evaluated, 18 clinical responses (3 CR, 15 PR), 8 cases of stable disease and 5 of progressive disease have been documented after ≥3 courses. Median time to progression, duration of response and survival have not yet been reached. Conclusion: In this small, heterogeneous group of pts, q3w H plus chemotherapy seems to be as well tolerated and active as weekly H. No significant financial relationships to disclose." @default.
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• W4235322571 date "2004-07-15" @default.
• W4235322571 modified "2023-10-16" @default.
• W4235322571 title "Three-weekly (q3w) trastuzumab (H) plus chemotherapy in HER2-positive recurrent breast cancer (RBC)" @default.
• W4235322571 doi "https://doi.org/10.1200/jco.2004.22.90140.842" @default.
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