A Phase II Study of First-Line Chemotherapy with Weekly Carboplatin Plus Gemcitabine in Advanced Non-Small Cell Lung Cancer

Background: Optimal management of elderly patients (≥70 years) with non-small cell lung cancer (NSCLC) remains debatable. We compared survival and treatment of advanced NSCLC between elderly and younger patients. Methods: From the cancer registry, we identified 188 patients treated with chemotherapy for stage IV NSCLC. Patient characteristics, survival, toxicity, chemotherapy regimen and response were compared between age groups (patients 50-69 vs. ≥70 years). Results: There were 96 young and 92 elderly patients. The majority were male (70%) and had adenocarcinoma (53%). More elderly had an ECOG performance status >1 (59 vs. 42%, p = 0.04). Median survival was longer for young patients (11.5 vs. 10.8 months, hazard ratio, HR 1.43, p = 0.04). Patients ≥75 years had a significantly worse outcome compared to the young and patients aged 70-74 years (11.5 vs. 12.8 vs. 7.7 months, HR 1.71, p = 0.01). Hospitalization rate did not differ. Elderly had more hematological toxicities (56 vs. 32%, p = 0.01) and less frequently received first-line platinum combinations (96 vs. 69%, p < 0.001). Conclusions: Elderly patients had a marginally worse survival compared to young patients. Despite the less frequent use of combination chemotherapy, elderly patients experienced toxicity more often. Survival of those ≥75 years was significantly worse, indicating the urgent need of further research particularly in this age group.

Section: Discussionsupporting

confidence: 62%

Management of Elderly Patients with Advanced Non-Small Cell Lung Cancer: A Single-Center Experience

Früh

Besrour²,

Gillessen³

et al. 2013

“…However, recent studies of platinum-based chemotherapy have demonstrated manageable toxicity and feasible efficacy in patients with a poor PS (ECOG PS 2) and/or in elderly patients [32,33,34,35,36,37,38,39]. Therefore, our results suggest that a biweekly schedule of docetaxel and cisplatin may be more suitable, particularly for high-risk patients with unresectable NSCLC, than weekly regimens because patients enrolled into the present study had at least one poor prognostic factor (70.8% had a poor PS and/or 52% were elderly).…”

Section: Discussionmentioning

confidence: 99%

Phase II Trial of Biweekly Chemotherapy with Docetaxel and Cisplatin in High-Risk Patients with Unresectable Non-Small Cell Lung Cancer

Kim

Kang

et al. 2013

Purpose: We investigated the efficacy and toxicity of a biweekly schedule of docetaxel and cisplatin in high-risk patients with unresectable (stages IIIB-IV) non-small cell lung cancer (NSCLC). Methods: In this study, 48 high-risk patients with previously untreated locally advanced or metastatic NSCLC were treated with combination chemotherapy consisting of docetaxel 40 mg/m² and cisplatin 40 mg/m²; both drugs were given biweekly, on days 1 and 15, every 4 weeks in an outpatient setting. Results: Complete response, partial response, and stable disease were observed in 1 (2.1%), 30 [62.5%, 95% confidence interval (CI) 47.9-77.1], and 4 (8.3%) patients. The median overall survival was 15.1 months (95% CI 11.7-18.5) and the median time to progression was 7.5 months (95% CI 6.4-8.6). The major toxicity was grade 3 anemia in 7 (14.6%) patients. Grade 3/4 neutropenia was observed in 5 (10.4%) patients. Among the nonhematologic toxicities, grade 3 infection and grade 3 diarrhea were observed in 5 (10.4%) and 4 (8.3%) patients, respectively. No treatment-related mortality was found. Conclusions: As a front-line chemotherapy for high-risk patients with unresectable NSCLC in an outpatient setting, the biweekly schedule of docetaxel and cisplatin showed feasible efficacy with acceptable hematologic toxicities, comparable to the results of previous studies of triweekly or weekly schedules. Additional large randomized studies are needed to optimize the schedule and dosage of combination therapy with docetaxel and cisplatin in high-risk patients with unresectable NSCLC.

“…The GC regimen was tested in various situations of NSCLC patients, e.g. in an adjuvant setting, for elderly patients and as a second-line treatment for selected patients with encouraging effects [16,18,19,20,21]. In addition, acceptable toxicity and promising median overall survival rates were reported in the combination of GC and bevacizumab for nonsquamous NSCLC [22].…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, in clinical practice, the biweekly GC regimen provides more potential treatment options suitable for use on an outpatient basis. Furthermore, the GC regimen combined with bevacizumab has been reported to be well tolerated and active in nonsquamous NSCLC [21]. The biweekly GC regimen may improve the usage of GC regimens in combination with molecular targeted drugs.…”

Section: Discussionmentioning

confidence: 99%

A Randomized Phase II Trial of Gemcitabine plus Carboplatin: Biweekly versus Standard Schedules in Patients with Advanced Non-Small Cell Lung Cancer

Hasegawa

Miura²,

Kitamura³

et al. 2013

Objective: Gemcitabine combined with carboplatin (GC) is a widely used regimen for advanced non-small cell lung cancer (NSCLC), but clinical outcome is still hampered by its toxicity. We conducted a randomized phase II study of GC and compared biweekly versus standard schedules in patients with advanced NSCLC with respect to toxicity and outcome. Methods: Forty patients with stage IIIB or IV NSCLC were randomized to receive either a biweekly regimen of GC [gemcitabine (1,000 mg/m² on days 1 and 14) and carboplatin (area under the concentration-time curve, AUC = 3 on days 1 and 14)] every 28 days or a standard regimen of GC [gemcitabine (1,000 mg/m² on days 1 and 8) and carboplatin (AUC = 5 on day 1)] every 21 days. These cycles were repeated until disease progression. Results: Response rates were 55% for the biweekly regimen and 40% for the standard regimen. Median overall and progression-free survival times were 19.7 and 6.2 months, respectively, for the biweekly regimen, and 11.8 and 2.8 months, respectively, for the standard GC regimen. Hematologic toxicity was prominent. However, the incidence of grade 1 or 2 thrombocytopenia was significantly lower in the biweekly than in the standard GC regimen (p < 0.05). Nonhematologic toxicity was mild. Conclusion: A biweekly GC regimen was better tolerated than a standard GC regimen in patients with advanced NSCLC.