138 Gemcitabine in the treatment of pretreated metastatic non small cell lung cancer: A preliminary report

Piazza, E.; Isa, L.; Pavia, Gianfranco; Tosca, Nicoletta; Candido, P.; Gambaro, Anna; Ferrario, S.; Orlandini, Beatrice; Raina, Anant; Giorgetti, Melania; Clerici, M.; Cattaneo, María Teresa

doi:10.1016/s0169-5002(97)89417-2

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“…In this study and in other studies in pretreated patients (Crinó et al, 1997a;Guerra et al, 1997;Piazza et al, 1997;Rosvold et al, 1998), single-agent gemcitabine as second-line therapy produced an overall response rate of approximately 20%, which is similar to response rates observed in single-agent gemcitabine studies in untreated patients, who are not cross-resistant with other agents commonly used in this setting. Given an appropriate regimen, gemcitabine is considered to interact synergistically with cisplatin to enhance its cytotoxicity as evidenced by the clinical results observed in first-line treatment with gemcitabine-cisplatin combination regimens producing response rates of 30-50% (Abratt et al, 1997;Crinó et al, 1997b;Einhorn, 1997;Shepherd et al, 1997).…”

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confidence: 84%

Single-agent gemcitabine in pretreated patients with non-small-cell lung cancer: results of an Argentinean multicentre phase II trial

Kooten

Traine²,

Cinat³

et al. 1999

Br J Cancer

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The activity and mild toxicity profile of single-agent gemcitabine therapy in untreated (chemonaive) patients with non-small-cell lung cancer (NSCLC) is well documented. This phase II trial was conducted to determine the objective tumour response rate and toxicity profile of single-agent gemcitabine in pretreated patients with NSCLC. Patients with histological evidence of advanced NCSLC stage IIIB or IV; at least one prior chemotherapy regimen including a platinum or taxane analogue; an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; clinically measurable disease; adequate bone marrow reserve; and adequate renal function; received 1000 mg m –2 gemcitabine administered over 30 min on days 1, 8 and 15 of a 28-day cycle defined as 3 weekly treatments followed by 1 week of rest. Twenty-nine patients were evaluated for efficacy and 32 for toxicity. One patient achieved a complete response and five patients had a partial response resulting in a total response rate of 20.6% (95% confidence interval (CI) 6–34). Median response duration was 7 months (range 4–11 months). Twelve (41%) patients reached stable disease after two cycles of therapy and 11 (38%) patients had disease progression. Median progression-free survival time was 3 months and median overall survival time was 5.5 months. Toxicity was generally mild (grades 0–2). Severe (grade 3 or 4) haematological toxicities included grade 3 anaemia in one patient and grade 3 thrombocytopenia in two patients. Severe non-haematological toxicities included one patient each with grade 3 liver transaminase elevations, nausea/vomiting and diarrhoea. This study confirms the activity and safety of single-agent gemcitabine in pretreated patients with advanced NSCLC who are refractory or sensitive to first-line therapy. © 1999 Cancer Research Campaign

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