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Randomized phase II trial comparing every-3-week carboplatin/paclitaxel (C/P) versus every-3-week C with weekly P in advanced non-small cell lung cancer (NSCLC).

7073 Background: C/P remains a commonly used regimen in advanced NSCLC although the optimal dose/schedule of both agents remains controversial. We designed a randomized phase II trial addressing a pure schedule question over 4 cycles of C/P in the first-line setting.


METHODS
Patients (pts) with stage IIIB/IV NSCLC are randomized to either C AUC 6 plus P 225 mg/m2 every 3 weeks for 4 cycles (Arm A) or C AUC 6 every 3 weeks for 4 cycles with P 75 mg/m2/wk x 12 (Arm B). Total cumulative doses of P on both arms are identical as is the schedule of C. The FACT-L QoL instrument is being performed at baseline and at 6 and 12 weeks while on C/P.


RESULTS
Thus far, 145 of a planned 160 pts have been randomized (Evaluable thus far, n= 67 Arm A, n= 69 Arm B). Patient characteristics: median age 60 yrs (range 38-85), 64% male, 89% stage IV: 11% IIIB, 52% KPS 70-80; 48% KPS 90-100%, 51% > 5% wt loss. All characteristics are well balanced between the arms. A median of 4 cycles have been delivered on Arm A and 12 wks of weekly C/P on Arm B. Grade 3/4 hematologic toxicities are not significantly different between the two arms. Grade ≥ 2 non-hematologic toxicities are not significantly different except for myalgia/arthralgia which was less frequent on Arm B (4% Arm B vs 18% on Arm A, p=0.03). Rates of ≥ grade 2 neuropathy are 15% and 12% on Arm A and B, respectively (p=0.8). Response rates (RR) are 28% on Arm A and 35% on Arm B (stable disease rates are 39% and 33%, respectively). Median survival of all pts thus far is 8.3 months (95% CI, 6.4-9.0) with a median survival of 7.3 months (95% CI, 5.9-8.6) and 8.7 months (95% CI, 6.5-10.4) for Arms A and B, respectively. The QoL information from the FACT-L will be presented.


CONCLUSIONS
1) Weekly C/P given on this schedule has less non-hematologic toxicity in the form of myalgia/arthralgia, 2) RR and overall survival are similar on both the arms of the trial, 3) This schedule and dose of weekly paclitaxel in combination with C every-3-wks appears active and well-tolerated in advanced NSCLC [Table: see text].