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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-038 - Phase III Trial of Pemetrexed/Carboplatin vs Pemetrexed Only in Chemo-Naïve Elderly Non-SQCC NSCLC Patients Aged ≥ 70 (ID 5036)
14:30 - 14:30 | Author(s): S. Seo
- Abstract
Background:
We aimed to compare pemetrexed/carboplatin doublet (PC) versus pemetrexed singlet (P) as induction therapy in chemotherapy-naïve elderly patients aged 70 or more with advanced non-squamous non–small-cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Methods:
In this open-label multicenter phase III randomized trial, elderly patients aged 70 or more with advanced non-squamous NSCLC, ECOG PS of 0-1, no prior chemotherapy, adequate organ function and measurable disease were assigned to PC doublet (P, 500 mg/m2; C, area under the curve of 5) or P singlet (500 mg/m2) after stratified randomization according to center, gender and Charson Comorbidity Index (CCI). The treatment was given every 3 weeks till disease progression, unacceptable toxicity or withdrawal of consent. However, carboplatin was given for only the first four cycles during induction therapy period. The primary end point was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, and safety.
Results:
A total of 267 eligible patients were enrolled from six centers between March 2012 and October 2015; median age was 74 years (70~86); 95% had PS of 1; 68% were men; and 61% had CCI of 1 or more. The median PFS was 5.4 months for PC doublet and 4.2 months for P singlet, respectively (hazard ratio [HR], 0.85; 95% CI, 0.65 to 1.11; P= 0.2353). The median survival time was 12.5 months for PC and 9.0 months for P, respectively (HR, 0.86; 95% CI, 0.62 to 1.21; P =0.4108). The objective response rates for PC doublet and P singlet were 34.7% and 25.9%, respectively (p=0.1387). The most common adverse events in PC doublet arm were anemia (9.6%), fatigue (8%) and pneumonia (6.4%) while those in P singlet arm were pneumonia (4.2%), fatique (3.3%) and anemia (2.5%) in descending of frequency.
Conclusion:
The addition of carboplatin to pemetrexed during induction therapy period did not show the improvement of survival time in elderly patients aged 70 or more with advanced non-squamous NSCLC and ECOG PS of 0-1 even though it increased the response rate numerically. Updated data will be presented.
