P is approved in the EU and US as 1st-line therapy in combination with docetaxel and trastuzumab (H) for HER2-positive mBC based on phase III results (CLEOPATRA). Data in later lines are very limited. In Switzerland, national regulations allow physicians to use P in this setting. We identified P-naïve patients (pts) treated with ≥2nd-line P+H in Switzerland to gain insight on clinical outcomes with P beyond 1st line.
Physicians from major Swiss oncology centres retrospectively completed a questionnaire for each pt providing data on treatment details, safety and survival.
The analysis included 35 pts with HER2-positive mBC. Most pts (95%) had invasive ductal carcinoma, 69% had oestrogen- and/or progesterone receptor-positive tumours, 49% were stage IV at 1st diagnosis and half had received prior H. Median age was 49 (range 35–87) years. The most common metastatic sites were bone (64%), liver (43%) and lymph nodes (43%). Analysis of the earliest line of P is shown below.
In this small retrospective analysis, median overall survival was similar to that reported with 1st-line P in CLEOPATRA. Diarrhoea was generally unproblematic and low grade; cardiac safety was as expected. These data support P in later lines if not used in the 1st line.
Jennifer Kelly (Medi-Kelsey Ltd), funded by Roche Pharma (Schweiz) AG.
Dr Biskup and Dr Vetter.
Roche Pharma (Switzerland) provided administrative support for this analysis.
A. Müller: Honoraria: Roche Switzerland, Novartis, Pfizer, Amgen, Tesaro; Consulting/advisory role: Roche Switzerland, Novartis, AstraZeneca, Pfizer, Amgen; Expert testimony: Roche Switzerland; Travel/accommodation expenses: Roche, AstraZeneca, Pfizer, Novartis. C. Leo: Honoraria: Pfizer, AstraZeneca; Consulting/advisory role: Pfizer, AstraZeneca; Travel/accommodation expenses: Roche. C. Uhlmann Nussbaum: Stock: Roche; Consulting/advisory role: Sanofi, Boehringer Ingelheim, Roche. D. Koychev: Consulting/advisory role: Roche, Novartis, Takeda, Pfizer; Travel/accommodation expenses: Novartis, Roche, Takeda. A. Schreiber: Honoraria: Amgen, Roche, Pfizer, MSD, BMS, Lilly, Celgene, Merck; Travel/accommodation expenses: Amgen, Roche, Pfizer, MSD, BMS, Lilly, Celgene, Merck. C. Taverna: Consulting/advisory role: Celgene, Amgen, Janssen; Research funding: Celgene. D. Thorn: Honoraria: Roche; Consulting/advisory role: Roche; Travel/accommodation expenses: Roche, Amgen, Teva, Novartis, Celgene. M. Vetter: Employment: Roche (family member); Honoraria: Roche, Novartis, Pfizer; Consulting/advisory role: Roche, Novartis, Pfizer; Research funding: Roche. All other authors have declared no conflicts of interest.
Grade (G) 3/4 adverse events (AEs) were reported in 14% of pts. Only 1 pt discontinued therapy because of P-related toxicity. The most common AE (irrespective of cause) was fatigue (all-G 46% of pts; G3 11%). Congestive heart disease occurred in 14% (6% G3), nausea in 14% (all G1), myelosuppression in 12% (6% G3), diarrhoea in 9% (all G1) and vomiting and mucositis each in 3% (G2). By 12 Sep 2017, 20 pts (57%) had died. Median overall survival was 6.2 (95% CI 3.9–11.6) years.Treatment Treatment line All pts 2nd 3rd ≥4th (n = 14) (n = 6) (n = 15) (n = 35) P + H + chemotherapy, n (%) 12 (86) 5 (83) 12 (80) 29 (83) Taxane 8 (57) 4 (67) 7 (47) 19 (54) Vinorelbine 3 (21) 1 (17) 2 (13) 6 (17) Gemcitabine 0 0 1 (7) 1 (3) Carboplatin 0 0 1 (7) 1 (3) Anthracycline 1 (7) 0 1 (7) 2 (6) P + H + endocrine therapy, n (%) 1 (7) 0 0 1 (3) P + H, n (%) 1 (7) 1 (17) 3 (20) 5 (14) Median P duration (range), months 6 (2–30) 6 (2–60) 11 (2–40) 6 (2–60) Reason for stopping treatment, n (%) Disease progression 10 (71) 4 (67) 9 (60) 23 (66) Toxicity 2 (14) 1 (17) 2 (13) 5 (14) Missing 1 (7) 1 (17) 2 (13) 4 (11) Ongoing 1 (7) 0 2 (13) 3 (9)