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P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
P1.12-20 - Overall Survival with Lurbinectedin Plus Doxorubicin in Relapsed SCLC. Results from an Expansion Cohort of a Phase Ib Trial. (ID 13245)
16:45 - 18:00 | Author(s): Rafael Nuñez
Lurbinectedin (PM01183, L) is a new anticancer drug that binds to DNA, inhibits transactivated transcription and modulates tumor microenvironment. Preclinical evidence of synergism was observed for PM01183 in combination with doxorubicin (DOX).a9ded1e5ce5d75814730bb4caaf49419 Method
This multicenter, phase Ib clinical trial found impressive activity in second-line SCLC patients (ORR 67%). An expansion cohort with reduced dose (L 2mg/m2+ DOX 40mg/m2) was implemented to improve safety. SCLC patients <75 years with ECOG PS 0-1 and with no more than one prior chemotherapy line and stable brain metastases were included. DOX was interrupted after 10 cycles continuing with PM01183 alone. Primary G-CSF prophylaxis was not mandatory.4c3880bb027f159e801041b1021e88e8 Result
27 patients treated. Males: 75%; median age: 64 (49-77) years; ECOG PS 0-1: 32%-68%; CNS involvement: 4%; bulky disease (>50 mm): 75%. 88% responded to 1st line (CR in 4%). Median chemotherapy-free interval (CTFI) was 3.5 months (m). 22% refractory (CTFI <30 days) 15% resistant (R) (CTFI 30-90 days) and 63% sensitive (S) (CTFI>90 days). Overall confirmed ORR was 37% (CR in 4%), and 53% (CR in 6%) in S patients. Overall median PFS was 3.4 m (95% CI, 1.5-6.2), being 1.5 m (95%CI, 0.8-3.4) in R pts, and 5.7 m in S patients. Overall survival (OS) data are summarized in the following table.
(95% CI: 4.9-11.5)
(95% CI: 2.3-6.7)
(95% CI: 6.0-16.6)
Excluding CTFI<30days (n= 21)
(95% CI: 6.0-12.1)
(95% CI: 5.1-8.4)
(95% CI: 6.0-16.6)
Data shown are median and 95% CI.
Grade 4 neutropenia, anemia or thrombocytopenia appeared in 64%/0%/7% of patients, respectively, and febrile neutropenia (G3/4) occurred in 10%. Non-hematological toxicity was mild and mainly due to fatigue (G3=18%) and nausea (G3=7%).8eea62084ca7e541d918e823422bd82e Conclusion
Lurbinectedin/DOX combination showed remarkable activity as second line in SCLC, especially in sensitive patients (CTFI>90 days). Activity is higher than that reported for CAV or topotecan. OS shows an outstanding improvement in this second-line setting, especially when excluding refractory pts. A phase III clinical trial (ATLANTIS, NCT02566993) is currently ongoing evaluating this combination in relapsed SCLC patients6f8b794f3246b0c1e1780bb4d4d5dc53
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