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H. Saito
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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
- Moderators:A. Molasiotis, P. Van Houtte
- Coordinates: 9/08/2015, 16:45 - 18:15, 708+710+712
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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): H. Saito
- Abstract
- Presentation
Background:
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.
Methods:
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).
Results:
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).
Conclusion:
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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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-080 - Pemetrexed, Carboplatin and Bevacizumab in Patients with Non-Squamous NSCLC without or with Activating EGFR Mutation (CJLSG0909/0910) (ID 615)
09:30 - 17:00 | Author(s): H. Saito
- Abstract
Background:
Treatment strategies for advanced non-squamous (sq) non-small cell lung cancer (NSCLC) are divided by EGFR mutations. However, there has been no previous report about efficacy of cytotoxic agents separated by EGFR mutations. In addition, the influence of the EGFR mutations on the maintenance therapy with pemetrexed (Pem) or bevacizumab (Bev) has not been elucidated. We planned two studies designed to evaluate the efficacy and safety of combination therapy with Pem, carboplatin (Cb) and Bev followed by Pem and Bev maintenance therapy for non-sq NSCLC patients without or with activating EGFR mutation.
Methods:
We undertook two multicenter, open-label, single-arm, phase II studies. Patients with wild type EGFR or with EGFR mutation (exon 19 deletions or exon 21 point mutation) entered CJLSG0909 or 0910, respectively. Patients received Pem 500mg/m[2], Cb AUC 6, and Bev 15mg/kg day1, every 3 weeks, 4 to 6 cycles (induction therapy). Patients who had achieved disease control received Pem+Bev maintenance therapy until progressive disease or unacceptable adverse event. Key inclusion criteria were stage IIIB, IV, or recurrent disease after surgery, no prior chemotherapy, age 20 to 74. The primary endpoint was the objective response rate (ORR), and the secondary endpoints were the disease control rate (DCR), progression free survival (PFS), overall survival (OS) and safety. (Unique trial Number; UMIN000003736/UMIN000003737)
Results:
In CJLSG0909, 50 patients received induction treatment. They had a median age of 64 years and were predominantly men (40 [80%]) with adenocarcinoma (47 [94%]), stage IV (40 [80%]), and a performance status (PS) of 1 (40 [80%]). The median of induction therapy was 5 cycles. Thirty-five (70%) patients received maintenance therapy, and the median of maintenance therapy was 5 cycles. Partial response was observed in 25 patients with a ORR of 50.0% (95% confidence interval, 33.7–62.6%). Stable disease was observed in 21 patients and the DCR was 92%. Median PFS was 6.8 months and median OS was 19.4 months. Grade 3/4 toxicities during induction therapy included neutropenia (40 [80%]), thrombocytopenia (12 [24%]), anemia (8 [16%]), nausea (4 [8%]), anorexia (3 [6%]), ALT elevation (3 [6%]), AST elevation (2 [4%]), vomiting, periodontal, hemoptysis, thrombosis and proteinuria (1 [2%]) respectively. In CJLSG0910, 30 patients received induction treatment. They had a median age of 65.5 years and were predominantly women (17 [57%]) with adenocarcinoma (29 [97%]), stage IV (27 [90%]), and a PS of 0 (23 [77%]). The median of induction therapy was 6 cycles. Twenty-five (83%) patients received maintenance therapy, and the median of maintenance therapy was 8.5 cycles. Partial response was observed in 15 patients with a ORR of 50.0% (95% confidence interval, 33.9–66.1%). Stable disease was observed in 15 patients and the DCR was 100%. Median PFS was 10.0 months and median OS was 41.4 months. Grade 3/4 toxicities during induction therapy included neutropenia (14 [47%]), thrombocytopenia (6 [20%]), anemia (6 [20%]), diarrhea (2 [7%]), nausea, anorexia, amylase elevation (1 [3%]) respectively.
Conclusion:
These studies suggested that chemotherapy with Pem+Cb+Bev, including Pem+Bev maintenance therapy is candidate for first line therapy in non-sq NSCLC patients regardless of the activating EGFR mutations.
