Trastuzumab beyond first progression in cases of HER2-positive advanced gastric or gastro-esophageal junction cancer: Initial results from KSCC1105, a trastuzumab observational cohort study
| Autor: | Tetsuya Kusumoto, Yoshihiko Maehara, Yasunori Emi, Eiji Oki, Hiroshi Saeki, Mototsugu Shimokawa, Akitaka Makiyama, Ikuo Takahashi, Tomomi Kashiwada, Yoshihiro Kakeji, Kazuharu Yamamoto, Hiroshi Ishikawa, Yuji Negoro, Hideo Baba |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment Gastro esophageal junction macromolecular substances 03 medical and health sciences 0302 clinical medicine Trastuzumab Internal medicine medicine Adverse effect Chemotherapy business.industry Cancer medicine.disease Metastatic breast cancer Surgery 030104 developmental biology 030220 oncology & carcinogenesis Baseline characteristics business medicine.drug Cohort study |
| Zdroj: | Journal of Clinical Oncology. 35:93-93 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 93 Background: The concept of using trastuzumab (Tmab) beyond progression (TBP) is currently accepted in HER2-positive metastatic breast cancer. However, TBP has never been investigated in cases of HER2-positive advanced gastric or gastro-esophageal junction (G/GEJ) cancer. KSCC1105 is an observational cohort study designed to investigate the clinical outcomes associated with Tmab combined with chemotherapy including TBP strategy in part, as used in clinical practice, for the treatment of advanced G/GEJ cancer. Methods: Patients (pts) with advanced HER2-positive G/GEJ cancer receiving Tmab between March 2011 and January 2014 were enrolled. Data regarding the baseline characteristics before Tmab plus chemotherapy, pre-specified Tmab-related adverse events, and effectiveness were collected retrospectively. Treatment outcomes were estimated using Kaplan-Meier method and compared using log-rank test. Results: Of 181 enrolled pts, 179 were eligible for analysis and 123 received Tmab as first-line chemotherapy. Among the 123 pts, 85 were able to undergo second-line therapy with or without Tmab. We divided these 85 pts into those treated with Tmab (TBP group, n = 59; 69%) and those treated without Tmab (non-TBP group, n = 26; 31%) in the second-line chemotherapy. The baseline characteristics were similar between the two groups. The median OS was significantly longer in the TBP group (12.8 months; 95% CI 9.0–16.5 months) than in the non-TBP group (7.9 months; 95% CI 5.1–10.7 months) (hazard ratio = 0.50; 95% CI 0.29–0.84; p = 0.010). Infusion-related events were more frequent in the TBP group (20.3%) than in the non-TBP group (11.5%); however, no significant difference was observed. No cardiac event-related death was observed in either group. Conclusions: TBP may be associated with a better prognosis, without severe toxicity. A randomized controlled trial to assess TBP (T-ACT trial; WJOG7112G) is currently being undertaken by the West Japan Oncology Group. |
| Databáze: | OpenAIRE |
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