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ORAL 29 - MASCC-IASLC Joint Session: Palliative and Supportive Care (ID 136)
- Event: WCLC 2015
- Type: Oral Session
- Track: Palliative and Supportive Care
- Presentations: 1
ORAL29.02 - ONO-7643/Anamorelin for the Treatment of Cancer Cachexia in Advanced NSCLC Patients: Results From the Phase 2 Study in Japan (ID 1375)
16:45 - 18:15 | Author(s): T. Yokoyama
Cancer cachexia is characterized by decreased body weight (BW), mainly lean body mass (LBM) and negatively impacts quality of life (QOL) and prognosis. ONO-7643/anamorelin (ANAM) is a novel selective ghrelin receptor agonist with appetite-enhancing and anabolic activity.
ONO-7643-03 was a double-blind, exploratory Phase 2 trial assessing ANAM efficacy and safety in Japanese non-small cell lung cancer (NSCLC) patients with unresectable stage III/IV NSCLC, ECOG performance status (ECOG PS) 1-2 and cachexia (main criteria: ≥5% weight loss within prior 6 months). Patients were randomized to ANAM at 100 or 50 mg, or placebo, given daily orally for 12 weeks. Co-primary endpoints were change from baseline over 12 weeks in LBM (measured by DXA) and handgrip strength (HGS). Secondary endpoints included change in BW, ECOG PS, Karnofsky performance scale (KPS) and QOL assessment (QOL-ACD).
Demographics were balanced (N=180); median age=66 yr, male (68.9%), ECOG PS=1 (77.5%) and stage IV (76.1%). Treatment effects: the change in LBM over 12 weeks was 0.55 kg in the placebo arm and 1.15 kg in the ANAM 100 mg arm, and the change in LBM at both Weeks 8 and 12 showed significant differences between ANAM 100 mg and placebo (p<0.05). However, the change in HGS was similar between arms at both time points. The change in BW to Weeks 12 was -0.93 kg in the placebo arm vs +0.54 kg in the 50 mg arm and +1.77 kg in the 100 mg arm, and was significantly different between the 100 or 50 mg arms and the placebo arm at all time points (p<0.05). The cumulative rate of deterioration of ECOG PS was lowest in the 100 mg arm, and ANAM 100mg significantly improved KPS and QOL-ACD compared to placebo at Weeks 4 and 12 (p<0.05). Regarding safety, ANAM treatment for 12 weeks was well tolerated. While median survival time (MST) was not significantly different between active treatment arms and placebo, MST of patients with BW loss was significantly shorter than those without (215 vs 327 days; p=0.0055).
This phase 2 study demonstrated that ANAM has promising potential in improving body composition, performance status and QOL in patients with cancer cachexia.
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P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P3.07-015 - Final Report of Phase I/II Study of Induction Carboplatin and Irinotecan Followed by TRT for Elderly Patients with LD-SCLC: TORG 0604 (ID 3232)
09:30 - 17:00 | Author(s): T. Yokoyama
In elderly patients with LD-SCLC, the role of irinotecan has been unclear and the timing of TRT combined with chemo-therapy has not been fully evaluated. Furthermore, no standard treatment has been established for them. We report a phase I/II trial of induction chemotherapy of carboplatin and irinotecan followed by sequential TRT in this population.
Patients with untreated, measurable LD-SCLC >70 years with performance status (PS) 0 to 2 and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8 every 21 days for four cycles. TRT of 54Gy in 27 fractions was then administered sequentially. Carboplatin dose was escalated from AUC of 4 to 5 (Levels 1 and 2, respectively) with a fixed dose of irinotecan at 50 mg/m. The primary objective of the phase II portion was evaluation of efficacy.
A total of 41 patients were enrolled [median age 75 years, range 70-86 years; 31 male, 10 female; PS 0/1/2: 22/18/1]. At Level 1 (n=6), one patient experienced dose-limiting toxicity (DLT) as Grade 3 hypertension. At Level 2 (n=6), two patients experienced DLT as Grade 4 thrombocytopenia. Therefore, level 1 was chosen as the recommended dose. The phase II trial was then expanded by 35 patients in the level 1 based on the Simon minimax design. In all cohorts, the median chemotherapy cycle was 4 (1/2/3/4 courses administered as 4/2/2/33); median radiation dose was 54Gy (range 36-60). Toxicities were generally mild, as expected. Gr 3/4 leukopenia and thrombocytopenia were both observed in six (15%) patients. No Gr 3/4 diarrhea or esophagitis was noted. Although Gr 3 febrile neutropenia and Gr 3 pneumonitis were seen in two patients each, no treatment-related deaths occurred. There were five complete responses and 32 partial responses, for a response rate of 90%. With median follow-up of 80.4 months (n=41), median progression-free and overall survival times were 11.2 and 27.1 months, respectively.
Induction chemotherapy with carboplatin plus irinotecan followed by sequential TRT was well tolerated and highly effective in elderly patients with LD-SCLC. Further confirmatory studies are warranted.