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A. Groman
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OA12 - SBRT and Other Issues in Early Stage NSCLC (ID 383)
- Event: WCLC 2016
- Type: Oral Session
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:D. De Ruysscher, M.R. Mueller
- Coordinates: 12/06/2016, 11:00 - 12:30, Strauss 2
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OA12.01 - Phase II Randomized Study of 2 SBRT Regimens for Medically Inoperable Patients with Node Negative Peripheral NSCLC (ID 4342)
11:00 - 11:10 | Author(s): A. Groman
- Abstract
- Presentation
Background:
This phase II, multi-institutional (Roswell Park Cancer Institute, Cleveland Clinic, and Upstate Medical Center) randomized study was conducted to compare incidence of RTOG grade 3 or higher adverse events (AEs) associated with 2 different, established SBRT regimens for NSCLC
Methods:
Patients with documented baseline medical conditions precluding lobectomy and biopsy-proven peripheral (greater than 2 cm from the central bronchial tree) T1/T2, N0 (clinically node negative by PET), M0 tumors were eligible. Patients were randomized to receive either 30 Gy in one fraction (arm 1) or 60 Gy in 3 fractions (arm 2) over at least 8 days. Heterogeneity corrections were not used. Randomization was stratified by treatment center and Karnofsky performance status (100, 90, 80 and below.) The study was designed to detect whether psAEs rate > 17% at a 5% significance level (1-sided) and 81% power. Secondary endpoints included: local control, greater than 1 year toxicity, overall survival (OS) and progression-free survival (PFS).
Results:
The study opened in September 2008, was suspended between April 2010 to June 2010 as well as October 2010 to April 2011 while RTOG 0915 was open, and closed on April 15, 2015 after accruing a total of 98 patients. All patients received planned SBRT treatment. Median follow-up was 27 months. In follow-up, 10 patients were lost to follow-up; 1 was in arm 1 and 9 in arm 2. Baseline patient and tumor characteristics were balanced between both arms. On arm 1, 13 (27%) patients and 16 (33%) patients on arm 2 experienced RTOG grade 3 AEs, there were no grade 4 AEs. Thoracic grade 3 AEs were experienced by 8 (16%) patients on arm 1 and 6 (12%) patients on arm 2. There were no differences in OS or PFS survival, logrank p= 0.44 and 0.99 respectively. OS at 2 years was 71% (95% CI, 55-82%) for arm 1 and 61% (95% CI, 44-78%) for arm 2. PFS at 1 year was 63% (95% CI, 46-75%) for arm 1 and 51% (95% CI, 34-65%) for arm 2.
Conclusion:
This randomized phase II study demonstrated that 30 Gy in one fraction was equivalent to 60 Gy in three fractions in terms of toxicity, progression free survival and overall survival. Acknowledgment: Supported by Roswell Park Alliance Foundation grant
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P1.07 - Poster Session with Presenters Present (ID 459)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.07-001 - A Phase II Study of Etirinotecan Pegol (NKTR-102), a Topoisomerase-l lnhibitor Polymer Conjugate, in Small Cell Lung Cancer (ID 4349)
14:30 - 14:30 | Author(s): A. Groman
- Abstract
Background:
Small cell lung cancer (SCLC) has poor prognosis and systemic chemotherapy is the standard treatment. Irinotecan is a topoisomerase-I inhibitor that has been used in treating SCLC. Etirinotecan pegol (NKTR-102) is a polyethylene glycol conjugate of irinotecan. It is a next generation topoisomerase-I inhibitor uniquely designed for prolonged tumor cell exposure by using the polymer conjugate technology. This is a single arm phase II study to evaluate single agent etirinotecan pegol in patients with relapsed SCLC (NCT01876446).
Methods:
A total of 38 patients who have received only one prior systemic therapy for SCLC are being accrued over 3 years. There are 2 patient cohorts: those progressing on first-line chemotherapy <3 months after completion of treatment (Group A: chemotherapy-resistant, N=20) and those progressing on first-line chemotherapy ≥3 months after completion of treatment (Group B: chemotherapy-sensitive, N=18). Etirinotecan pegol was administered at 145 mg/m[2] IV once every 3 weeks. Cycles were repeated every 21 days until disease progression, unacceptable toxicity, or withdrawal from study. The primary endpoint is the 18-week progression free survival (PFS) rate. The secondary endpoints are objective response rate (ORR), duration of response (DOR), overall survival (OS) and toxicity. A single-stage design is used to assess the primary endpoint separately for each patient group.
Results:
Accrual of Group A is ongoing. Group B has completed targeted enrollment of 18 patients and the results are presented here. Median age was 61.6 (50-76.5) years, with 50% male. Prior chemotherapy included cisplatin/etoposide (41.2%) and carboplatin/etoposide (58.8%). Patients received a median of 6 (1-30) cycles of etirinotecan pegol, with dose reduction in 22.2%. PFS rate at week 18 was 72.2% (13/18, 95% Confidence Interval (CI): 47-90%). ORR was 44.5% (8/18), including one complete response. Another one-third (6/18) of patients had stable disease. Median DOR was 4 (1.4-14.5) months. Median PFS was 21.9 (95% CI: 11.7, 29.3) weeks, and OS was 7.1 (95% CI: 4.8, 14.7) months. The most common treatment-related adverse events (AEs) of any grade were diarrhea (66.7%), nausea (55.6%), fatigue (38.9%), and vomiting (27.8%). Neutropenia occurred in 2 cases, both grade 2, without neutropenic fever. The most common AEs ≥grade 3 were lymphopenia, hyponatremia and muscular weakness (2 cases each, all grade 3).
Conclusion:
Etirinotecan pegol has shown promising activity with acceptable toxicity profile in treatment of chemotherapy-sensitive patients with relapsed SCLC. Accrual of chemotherapy-resistant patients is expected to be completed soon.
