Quality-adjusted Outcomes Stratified by Response in Patients With Advanced Non–Small-cell Lung Cancer Receiving First-line nab-Paclitaxel/Carboplatin or Paclitaxel/Carboplatin

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Abstract

Micro-Abstract:

In the present analysis of quality-adjusted outcomes from a phase III trial of nab-paclitaxel/carboplatin versus paclitaxel/carboplatin to treat advanced non–small-cell lung cancer, the progression-free survival, overall survival, and quality-adjusted time without symptoms or toxicity duration were significantly longer for patients with a tumor response (early or late) compared with those without. These results support the use of the tumor response as a surrogate for long-term outcomes.

Background:

First-line nab-paclitaxel/carboplatin was associated with a significantly improved overall response rate (primary endpoint) versus paclitaxel/carboplatin in a phase III trial of advanced non–small-cell lung cancer (NSCLC). We report the results of an analysis evaluating the correlation of response and the time to response with survival and quality-adjusted outcomes.

Patients and Methods:

Using a landmark approach, progression-free survival (PFS), overall survival (OS), and quality-adjusted time without symptoms or toxicity (Q-TWiST) were compared between patients with a confirmed partial or complete response at or before 6 weeks (≤ 6-week responders) and those without (≤ 6-week nonresponders). The outcomes were also analyzed in two 12-week landmark analyses: ≤ 12-week responders versus ≤ 12-week nonresponders and early responders (≤ 6 weeks) versus late responders (6–12 weeks) versus ≤ 12-week nonresponders.

Results:

The median OS and PFS for the ≤ 6-week responders versus ≤ 6-week nonresponders were 14.5 versus 10.3 months (P < .001) and 5.5 versus 4.5 months (P = .002), respectively. The ≤ 6-week responders gained 2.1 months of mean Q-TWiST. The median OS and PFS for the ≤ 12-week responders versus ≤ 12-week nonresponders were 16.3 versus 8.4 months and 5.3 versus 2.8 months (both P < .001), respectively, and the ≤ 12-week responders gained 3.2 months of mean Q-TWiST. The median OS was 13.1, 16.6, and 8.4 months (P < .001), the median PFS was 4.1, 6.7, and 2.8 months (P < .001), and the mean Q-TWiST was 10.2, 11.7, and 7.8 months for the early responders, late responders, and ≤ 12-week nonresponders, respectively. Both early and late responders had significantly longer Q-TWiST compared with the ≤ 12-week nonresponders (difference, +2.4 and +3.9 months, respectively; P < .05).

Conclusion:

These results underscore response as an important surrogate for assessment of long-term treatment outcomes in advanced NSCLC.

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