99 Efficacy and toxicity profile of gemcitabine in previously treated patients with non-small cell lung cancer (NSCLC)

Cornejo-Guerra, José Antonio; Lianes, P.; Paz‐Ares, Luis; Castellano, Daniel; Gómez‐Martín, Carlos; Cortés-Funes, H.

doi:10.1016/s0169-5002(97)89378-6

Cited by 5 publications

(4 citation statements)

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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).…”

Section: Discussionsupporting

confidence: 84%

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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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Section: Discussionsupporting

confidence: 84%

“…In a single-agent gemcitabine study in pretreated patients with NSCLC, symptomatic benefit was evaluated and reported as significant (Guerra et al, 1997), although the value of gemcitabine as second-line therapy compared to that of best supportive care has yet to be determined in a randomized trial in pretreated patients.…”

Section: Discussionmentioning

confidence: 99%

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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“…[14][15][16][17][18][19][20] 78 0% to 14% 17 wks Vinorelbine [21][22][23] 43 0% to 20% Not reported Gemcitabine [24][25][26][27][28] 124 0% to 25% 17 wks (one trial) CPT-11 [29][30][31][32] 48 0% to 14% Not reported…”

Section: Discussionmentioning

confidence: 99%

“…In a small study reported by Guerra et al [26], 11 patients with NSCLC who were previously treated with cisplatinbased chemotherapy were treated with gemcitabine, 1250 mg/m 2 /week for a 3-week period every 4 weeks. Only one of 11 patients (9%) showed partial response, and overall median survival was only 17 weeks.…”

Section: Gemcitabinementioning

confidence: 99%

Second–line chemotherapy for non—small–cell lung cancer

Fossella

2000

Curr Oncol Rep

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Most of the experience with second-line chemotherapy for non-small-cell lung cancer (NSCLC) comes from small phase II trials, which have shown disappointing or inconsistent results. The notable exception has been docetaxel, which has been extensively studied as a second-line therapy for NSCLC. On the basis of consistent phase II activity, two large randomized phase III trials were conducted for patients with advanced NSCLC that had progressed either on or after first-line platinum-based therapy. In one trial, docetaxel, at either 100 or 75 mg/m(2), was compared with a regimen of either vinorelbine or ifosfamide. In the second trial, docetaxel 75 to 100 mg/m(2) was compared with best supportive care. Both trials showed significant improvement in survival, time to progression, and quality of life in the patients receiving docetaxel versus the control therapy. Based on these two large trials, it appears that the use of second-line therapy with single-agent docetaxel at a dose of 75 mg/m(2) every 3 weeks is a reasonable practice in patients who maintain a good performance status.

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Decreased myelotoxicity of gemcitabine and cisplatin in advanced non-small cell lung cancer (NSCLC) with cisplatin infusion on day 15

et al. 2001

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99 Efficacy and toxicity profile of gemcitabine in previously treated patients with non-small cell lung cancer (NSCLC)

Cited by 5 publications

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

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

Second–line chemotherapy for non—small–cell lung cancer

Decreased myelotoxicity of gemcitabine and cisplatin in advanced non-small cell lung cancer (NSCLC) with cisplatin infusion on day 15

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