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D.H. Lee
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- 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): D.H. Lee
- 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.
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P2.03a-061 - Randomized Phase II Trial Comparing Intercalation of Afatinib to Pemetrexed with Pemetrexed Alone after Failure of Platinum Doublet Therapy (ID 5813)
14:30 - 14:30 | Author(s): D.H. Lee
- Abstract
Background:
The combination of pemetrexed and erlotinib was synergistic in non-small cell lung cancer in vitro, if erlotinib exposure was avoided before pemetrexed. To enhance the efficacy of 2[nd]-line pemetrexed, we designed to test the sequential administration of afatinib followed by pemetrexed (pem+afa) compared with pemetraxed (pem) monotherapy.
Methods:
We performed randomized phase II trial in Asan Medical Center, Seoul, Korea. Patients with histologically or cytologically confirmed as non-squamous lung cancer were enrolled. Patients were stratified by response to 1[st] line treatment and smoking history, and randomly assigned in a 2:1 ratio to receive intravenous pemetrexed (500 mg/m2) on D1 followed by afatinib 40 mg/day on D2-15 or pemetrexed (500 mg/m2) on D1 every 3 weeks. The treatment was continued until disease progression. Primary end point was objective response rate (ORR), and secondary end points were progression-free survival (PFS) and overall survival (OS).
Results:
From August 2012 to July 2016, a total 87 patients (male, 71.3%; never smoker 31.0%; sensitive to 1[st]-line chemotherapy (PR+SD) 65.5%; median age 59 years) were randomized to pem (n=30) or pem+afa (n=57). Median follow-up duration was 12.4 months (range, 0.4-46.6 months). Median cycles administered were both 4 cycles in each groups (range, 1-37 in pem group; 1-62 in pem+afa group). Among 57 patients in pem+afa group, 26 patients (45.6%) underwent dose reduction (30 mg/day in 18 patients; 20 mg/day in 8 patients). By July, 2016, among 81 evaluable patients, 22 responses were noticed (4 in pem group; 18 in pem+afa group). ORR were 13.3% (4/30) and 31.6% (18/57) in pem and pem+afa, respectively (2-sided p value=0.074). Median PFS were 2.9 months and 5.7 months in pem and pem+afa, respectively (HR 0.718; 95% CI, 0.427-1.148; p=0.163). Median OS were 15.6 months and 12.1 months in pem and pem+afa, respectively (HR 1.393; 95% CI, 0.794-2.445; p=0.245).
Conclusion:
Intercalation of afatinib to pemetrexed looks better in numerically but statistically insignificant over pemetrexed monotherapy in 2[nd]-line treatment in EGFR unselected population with non-squamous lung cancer.
