Source: Cancer  |  Posted 8 years ago

In patients with advanced nonsmall-cell lung carcinoma (NSCLC), the combination of gemcitabine and carboplatin (GC) appears to be no more effective than mitomycin, ifosfamide, cisplatin (MIC) or mitomycin, vinblastine, cisplatin (MVP), according to the findings of a phase III trial.

MIC and MVP are accepted treatments for patients with advanced NSCLC. Gemcitabine is a relatively new treatment with a favorable side-effect profile that acts synergistically with platinum drugs. Thus, GC is an attractive candidate for comparison with standard therapies.

Sarah Danson, MD, Department of Medical Oncology, Christie Hospital National Health Service Trust, Manchester, United Kingdom, and colleagues studied 372 chemotherapy-naive patients with stage III/IV NSCLC who were ineligible for curative radiotherapy or surgery.

In the study, patients were randomized to receive either 4 cycles of gemcitabine (1000 mg/m[^]2[] on days 1, 8, and 15) plus carboplatin (area under the serum concentration-time curve, 5; day 1) every 4 weeks or MIC/MVP every 3 weeks.

Median survival was similar between the two groups (248 days in the MIC/MVP arm versus 236 days in the GC arm). Likewise, time to progression was also similar (225 days in the MIC/MVP arm versus 218 days in the GC arm).

The 2-year survival rate was 11.8% in the MIC/MVP arm and 6.9% in the GC arm. The 1-year survival rate was 32.5% in the MIC/MVP arm and 33.2% in the GC arm.

In the MIC/MVP arm, 33% of patients responded (4 complete responses [CRs] and 57 partial responses [PRs]), while 30% of patients in the GC arm responded (3 CRs and 54 PRs).

Grade 3-4 symptom nonhematologic toxicity was comparable between groups, although more alopecia occurred among patients in the MIC/MVP arm. GC appeared to produce more hematologic toxicity, however, and necessitated more transfusions. No differences in performance status or disease-related symptoms were observed, although fewer inpatient stays for complications were required with GC.

"In general, the quality-of-life data collected in the current study favored the GC combination," Dr. Danson and colleagues note. "In addition, any intervention that reduces the period of hospitalization, such as the GC regimen in the current trial, is particularly pertinent when survival tends to be short."

The authors conclude that this study did not reveal any statistically significant differences between GC and MIC/MVP.