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T. Evans
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-054 - Etirinotecan Pegol (NKTR-102) in the Treatment of Patients with Metastatic NSCLC after Failure of 2nd Line Treatment: A Phase II Study (ID 717)
09:30 - 17:00 | Author(s): T. Evans
- Abstract
Background:
3rd line treatment options are limited for patient (pts) with metastatic NSCLC. NKTR-102 is a long-acting topoisomerase-I inhibitor designed to concentrate in tumors and provide continuous exposure throughout the chemotherapy cycle. Based on clinical activity of irinotecan in NSCLC, we conducted a Phase II single arm trial to evaluate efficacy of NKTR-102.
Methods:
Pts >18 yrs with histologically proven NSCLC who received 2 prior systemic therapy regimens were eligible. Measurable disease, ECOG PS ≤1 and adequate end organ function were required. NKTR-102, 145mg/m2 was administered IV q3 weeks till progression. Response was assessed q6 weeks by RECIST 1.1. Primary endpoint was overall response rate. Secondary endpoints were progression free survival (PFS), overall survival (OS) and safety. Simon two-stage design was implemented; if 0/12 responses were observed in the 1st stage, the study would be terminated for futility. If there was at least 1 objective response in the 1st stage, the study would continue to stage 2, enrolling an additional 25 pts, for a total of 37.
Results:
Between 01/2013 and 01/2015, 37 pts have been enrolled. Median age 63 yrs (18-82), 45% female, ECOG PS 0=8 pts, 92% current/former smokers, 9 pts with squamous cell, 28 had adenocarcinoma. Median time from diagnosis to initiation of NKTR-102 was 18 mos (6-72). Pts received a median of 3 cycles (1-13). All pts were evaluable for response rate and toxicity. One pt in Stage I (adenocarcinoma) had a partial response. Fifteen pts had stable disease, 7 pts are still on treatment. 3 pts had Grade 3 GI toxicity attributable to NKTR-102. 6 pts required a dose reduction to 120 mg/m2 due to diarrhea. There was no hematological toxicity. Median PFS was 2.3 mos. For pts with >1 yr follow up (n=20), median OS was 5.5 mos. Complete PFS and OS data will be presented.
Conclusion:
NKTR-102 is well tolerated and leads to stabilization of disease in third line treatment of metastatic NSCLC. These clinical data combined with a favorable safety profile warrant further clinical investigation of this agent. Clinical trial information: NCT01773109.
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PLEN 04 - Presidential Symposium Including Top 4 Abstracts (ID 86)
- Event: WCLC 2015
- Type: Plenary
- Track: Plenary
- Presentations: 1
- Moderators:T. Mok, F.R. Hirsch
- Coordinates: 9/09/2015, 10:45 - 12:15, Plenary Hall (Bellco Theatre)
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PLEN04.03 - Randomized Phase III Trial of Adjuvant Chemotherapy with or without Bevacizumab in Resected Non-Small Cell Lung Cancer (NSCLC): Results of E1505 (ID 1608)
10:45 - 12:15 | Author(s): T. Evans
- Abstract
- Presentation
Background:
Adjuvant chemotherapy for resected early stage NSCLC provides modest survival benefit. Bevacizumab, a monoclonal antibody directed against vascular endothelial growth factor, improves outcomes when added to platinum-based chemotherapy in advanced stage non-squamous NSCLC. We conducted a phase 3 study to evaluate the addition of bevacizumab to adjuvant chemotherapy in early stage resected NSCLC. The primary endpoint was overall survival and secondary endpoints included disease-free survival and toxicity assessment.
Methods:
Patients with resected stage IB (>4 centimeters) to IIIA (AJCC 6th edition) NSCLC were enrolled within 6-12 weeks of surgery and stratified by chemotherapy regimen, stage, histology and sex. All patients were to receive adjuvant chemotherapy consisting of a planned 4 cycles of every 3 week cisplatin at 75 mg/m[2] with either vinorelbine, docetaxel, gemcitabine or pemetrexed. Patients were randomized 1:1 to arm A (chemotherapy alone) or arm B, adding bevacizumab at 15 mg/kg every 3 weeks starting with cycle 1 of chemotherapy and continuing for 1 year. Post-operative radiation therapy was not allowed. The study had 85% power to detect a 21% reduction in the overall survival (OS) hazard rate with a one-sided 0.025-level test.
Results:
From July 2007 to September 2013, 1501 patients were enrolled. Patients were 49.8% male, predominantly white (87.9%) with a median age of 61 years. Patients enrolled had tumors that were 26.2% stage IB, 43.8% stage II and 30.0% stage IIIA and 28.2% of patients had squamous cell histology. Chemotherapy options were utilized with the following distribution: vinorelbine 25.0%, docetaxel 22.9%, gemcitabine 18.9% and pemetrexed 33.2%. At a planned interim analysis, with 412 of 676 overall survival events needed for full information (60.9%), though the pre-planned futility boundary was not crossed, the Data Safety Monitoring Committee recommended releasing the trial results based on the conditional power of the logrank test. At the time of interim analysis, with a median follow-up time of 41 months, the OS hazard ratio comparing the bevacizumab containing arm (Arm B) to chemotherapy alone (Arm A) was 0.99 (95% CI: 0.81-1.21, p=0.93). The DFS hazard ratio was 0.98 (95% CI: 0.84-1.14, p=0.75). Completion of treatment per protocol was 80% on Arm A and 36% on Arm B. Statistically significantly increased grade 3-5 toxicities of note (all attributions) included: overall worst grade (67% versus 84%); hypertension (8% versus 30%), and neutropenia (33% versus 38%) on Arms A and B, respectively. There was no significant difference in grade 5 adverse events per arm with 16 (2%) on arm A and 19 (3%) on arm B.
Conclusion:
The addition of bevacizumab to adjuvant chemotherapy failed to improve survival for patients with surgically resected early stage NSCLC.
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