Phase II trial of gefitinib in pretreated Chinese women with advanced non-small-cell lung cancer
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A phase II clinical trial was performed to evaluate the efficacy and safety of gefitinib on pretreated Chinese female non-small-cell lung cancer (NSCLC) patients. Chinese female patients with locally advanced or metastatic NSCLC who failed at least one platinum-based chemotherapy received gefitinib monotherapy (250 mg/day) between April 2002 and January 2010. The primary endpoint was overall response rate (ORR), and secondary endpoints were overall survival (OS) and progression-free survival (PFS). Of the 40 evaluable female patients, the ORR was 62.5%. All patients have responded with one (2.5%) complete response, 24 (60%) partial response, 12 (30%) stable disease, and 3 (7.5%) progressive disease. The OS and PFS were 20 months (95% CI: 11.9–28 months) and 13 months (95% CI: 8.0–17.9 months), respectively. Survival (OS and PFS) were longer in patients with good performance status and in patients older than 65 years (P < 0.05). The most frequently observed toxicities were rash/dry skin (80%), diarrhea (42.5%), and vomiting/anorexia (32.5%). Four patients developed grade 3 toxicities (rash and diarrhea) but did not require either dose reduction or discontinuation. Gefitinib is a highly effective and well-tolerated agent for Chinese women with pretreated advanced NSCLC.
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- Phase II trial of gefitinib in pretreated Chinese women with advanced non-small-cell lung cancer
Volume 29, Issue 2 , pp 595-599
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- 1. Department of Medical Oncology, The First Hospital Affiliated to Medical School of Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, China
- 3. Department of Radiotherapy, Shaoxing People’s Hospital, 312000, Shaoxing, Zhejiang, China
- 4. Department of Medical Oncology, Xiaoshan Hospital, 311200, Hangzhou, Zhejiang, China
- 5. Department of Medical Oncology, Mingzhou Hospital, 315000, Ningbo, Zhejiang, China
- 2. Department of Oncological Surgery, The First Hospital Affiliated to Medical School of Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, China