Presenter: Rogerio C Lilenbaum Presenter's Affiliation: CALGB Type of Session: Plenary
The standard of care for patients with locally advanced NSCLC and good performance status (PS) is combination chemotherapy (CC). However, while CC has demonstrated increased tumor response rates, these often have not translated to increased overall survival rates. Moreover, data from selected trials and meta-analyses do not conclusively demonstrate that CC produces superior survival compared to optimal single-agent (SA) therapy. This CALGB phase III study evaluates the utility of CC versus SA therapy. The study also evaluates the impact of CC vs. SA on QoL and resource utilization.
Materials and Methods
The CALGB conducted a phase III randomized trial of carboplatin (C) and paclitaxel (P) (CP) vs. P alone in patients with stage IIIB and IV NSCLC
A total of 584 patients were entered from 10/97 to 1/01.
The study endpoints were survival, QoL, and cost-effectiveness.
Patients were stratified into: stage (IIIB/IV), PS (0-1/2), and age (>/<70).
The Treatment arms: P 225mg/m2 over 3 hours or the same P plus C at AUC of 6, both IV on day 1 every 3 weeks for up to 6 cycles.
The median age of the group was 63.5 years and 158 patients were 70 or older
There were more males than females M/F: 399/185
The majority of the patients had good PS PS 0-1/2: 470/100
Response rates were P 16% and CP 30% (p<0.0001).
Based on intention to treat analysis, with a median F/U of 12.5 months:
- Survival distributions were significantly different in favor of CC (p=0.023), with a median survival of 6.5 months for P and 8.5 months for CP
- However, the OS rates at 1-year 31% for P and 36% for CP, which did not reach statistical significance
Elderly patients (age 70 or greater) did not differ in survival from younger patients in the two arms
QoL results did not differ between the two groups;
Resource Utilization data did not show a significant difference
There was no difference in number of visits to the ER, Days in hospital, or Number of days in the ICU
The study shows that CC significantly improves the response rates and median survival as compared to SA therapy. CC did not increase overall survival; but, this could be attributed to the fact many 2nd line therapies contain carboplatin. The use of CC did not lower QoL or add more burden to the health care system in terms of cost. Elderly patients did not show a decrement in survival with CC. Poor PS patients, while not fairing well overall, did appear to benefit form CC.
This study not only supported previous conclusions regarding prolongation of life with combination chemotherapy, it specifically indicated that patient age, as an isolated factor, should not be a primary determinant of whether the use of combination chemotherapy is indicated. An economic evaluation of this study concluded that combination chemotherapy had acceptable efficacy and cost-effectiveness as compared with single?agent chemotherapy.
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