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H. Chen
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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): H. Chen
- 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.
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P2.04 - Poster Session with Presenters Present (ID 466)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.04-032 - Pulmonary Sarcomatoid Carcinoma (PSC): Experience of 45 Patients at a Comprehensive Cancer Center (ID 5389)
14:30 - 14:30 | Author(s): H. Chen
- Abstract
Background:
Pulmonary sarcomatoid carcinoma is rare and standard therapy is not well defined. We evaluated experience at our center to identify factors influencing the outcome.
Methods:
We performed a retrospective review of PSC patients (pts) treated at Roswell Park Cancer Institute between 1972 and 2014.
Results:
45 pts were identified. Cohort consisted predominantly of males (55%), Caucasians (91%) and smokers (87%) with an average 47 pack-year smoking history. Median age at diagnosis was 63 years. 22% presented with stage I, 25% with stage II, 22% with stage III and 31% with stage IV at diagnosis. All 13 pts tested for EGFR mutation were wild type. Mutations in KRAS were present in 3/11, ROS1 in 0/2, ALK in 0/9, RET in 0/2, BRAF in 0/2 and MET amplification in 1/2 pts. 29 pts underwent surgery. 80% had video assisted thoracoscopic surgery with 26 undergoing lobectomy and 3 pneumonectomy. 7 pts (16%) had neoadjuvant chemotherapy (CT). 6 of these received a cisplatin-based doublet (with gemcitabine, etoposide or pemetrexed), 1 received sarcoma-like regimen with cisplatin, paclitaxel and ifosfamide. 6 pts had partial response (PR) and 1 had progressive disease (PD). Adjuvant chemotherapy (AC) consisting of a platinum-based doublet was given in 10 pts. 41% pts who underwent surgery relapsed. Local relapse in the lung was the most common (77%). Systemic CT was given in 19 pts with stage IV or relapsed disease. First line CT was a platinum-based doublet in 74% pts. After a median of 2 cycles, only 1 patient had PR and 1 had stable disease. 88% pts had PD on first-line CT. Second-line CT was given in 11 pts, with combination or single agent (platinum, docetaxel, irinotecan, pemetrexed) or EGFR inhibitors in 3 pts. 5 pts underwent third-line CT. No pts had response to second- or third-line CT. Median progression free survival (PFS) was 4.9 months (m) and overall survival (OS) was 12.2 m and significantly depended on stage at diagnosis. Stage IV pts had PFS of 2.4 m and OS of 3.4 m. Pts receiving AC had significantly improved PFS (37 vs 13 m; p=0.026) and OS (48 vs 22 m; p=0.025).
Conclusion:
PSC heralds a poor prognosis and no standard management guidelines exist. AC is associated with significant improvemt in survival. Local relapse is the most common failure pattern in early-stage disease. In advanced stages, cytotoxic CT is ineffective with a short survival. There is a dire need for newer therapies.
