• Cancer Clinical Trials
• Respiratory Cancers

• Oncology
• Pulmonary & Respiratory Medicine

Researchers in Egypt conducting a prospective, Phase 3, randomized trial found no significant difference in time to progression (TTP) or overall survival (OS) in patients with stage IV advanced and metastatic non-small cell lung cancer (NSCLC) who received either gemcitabine or best supportive care (BSC) after induction therapy. Findings were displayed in a poster presentation.

Maintenance therapy in NSCLC has been extensively investigated. Evidence suggests that first-line cytotoxic combination chemotherapy should be stopped at disease progression or after 4 cycles in patients whose disease is nonresponsive to treatment [Brodowicz T et al. Lung Cancer 2006; Park 10 et al. J Clin Oncol 2007; Socinski MA et al. J Clin Oncol 2002; von Plessen C et al. Br J Cancer 2006].

Pretrexed continuation maintenance therapy is well tolerated and offers superior OS compared with placebo [PARAMOUNT (NCT00102804); Paz-Ares L et al. Lancet Oncol 2012], and maintenance therapy with erlotinib produced significantly longer progression-free survival [A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NCT00556712); Cappuzzo F et al. Lancet Oncol 2010].

The purpose of this study, which was conducted by the Clinical Oncology and Nuclear Medicine Department at Ain Shams University Hospitals in Cairo, Egypt, was to evaluate the efficacy—defined as prolongation of TTP, OS, and safety (grade 3 or 4 toxicity)—of low-dose gemcitabine as maintenance chemotherapy after first-line gemcitabine and cisplatin in advanced and metastatic NSCLC.

A total of 120 patients with advanced NSCLC presented at the Clinical Oncology and Nuclear Medicine Department at Ain Shams University Hospitals between January 2010 and June 2012. Of these, 75.5% were male, 70% were younger than 60 years, 59.2% had performance status (PS) 2, 2.75% had nonsquamous histology, and 79.2% had stage IV disease. All eligible patients received induction chemotherapy with gemcitabine and cisplatin.

Patients who completed 4 cycles and showed complete response, partial response, or stable disease were randomized into two arms: (1) gemcitabine 250 mg/m² given throughout 6 hours on days 1 and 8 every 3 weeks, or (2) BSC. Responses were assessed according to Response Evaluation Criteria in Solid Tumors guidelines every 2 cycles.

After each cycle, toxicities were evaluated according to National Cancer Institute criteria for common toxicities. Patients with progressive disease (PD) were excluded from the study, as were those who did not finish 4 cycles and showed doubling time, PD, or toxicity.

Results showed a median TTP of 6.1 months (CI, 5.3 to 6.6; p=0.454) in arm I and 5.8 months (CI, 5.2 to 6.4; p=0.454) in arm II. The median OS was 9 months (CI, 7.9 to 10.0; p=0.994) in arm I and 8 months (CI, 8.5 to 9.4; p=0.994) in arm II. The trial showed that maintenance therapy was well tolerated, with no grade 3 or 4 toxicity. The only significant finding was grade 2 anemia in 8 patients (22.9%) in the maintenance arm (arm I).

The clinical trial failed to show any statistical significance in TTP or OS between the 2 arms. The authors report that this could be due to the smaller sample size or the use of low-dose rather than conventional-dose gemcitabine. Other factors might include the predominance of nonsquamous histology and PS 2.

Evidence-based data indicate that this analysis of study outcomes is accurate. PS is among the most important prognostic factors for survival with NSCLC [Sweeney CJ et al. Cancer 2001]. PS, histology, and age versus comorbidity are the principal determinants of first-line treatment with cytotoxic combination chemotherapy, including platinum with gemcitabine. Treatment goals are to prolong survival and control disease-related symptoms. First-line treatment with platinum combinations, such as gemcitabine, yields similar improvements in survival [National Cancer Institute online 2014].

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