Abstract 1532P
Background
Most patients (Pts) with small-cell lung cancer (SCLC) have extensive-stage (ES) disease at diagnosis, and poor prognosis. First-line durvalumab (D) plus platinum–etoposide (EP) significantly improved overall survival in pts with ES-SCLC versus control group in CASPIAN study. CANTABRICO will assess safety and effectiveness of D plus EP in a real world ES-SCLC population in Spain.
Methods
CANTABRICO is a phase IIIb, single arm, multicentre study (NCT04712903). Eligible Pts were ≥18 years old with treatment-naive ES-SCLC, ECOG PS 0-2, with at least one measurable lesion. D (1500 mg) was concurrently administered with first-line cisplatin (CPT) or carboplatin (CP) d1 plus ET d1-3 every 3 weeks for 4 to 6 cycles (limited to 4 cycles in CASPIAN), followed by maintenance every 4 weeks until progressive disease or unacceptable toxicity.
Results
Between December 2020 and April 2021, 101 Pts from 35 sites in Spain were included. At data cut-off (February 28th 2022) all pts had finished chemotherapy (87% CP) and 25 pts were still receiving D. 56% of Pts were ≥ 65 years old, 67% were men, 94% had ECOG 0-1. 34%, 31% and 11% of Pts had liver, bone or brain metastases, respectively. 98% were current or former smokers and 10% had limited stage diagnosis. 32% of pts received 6 cycles of EP+D and 81% started D monotherapy. Median number of D doses were 8 (Interquartile range 5-11). Only 5 pts discontinued study treatment due to toxicity and all during EP+D phase: neurotoxicity, multiple sclerosis, nephritis and pneumonitis (2). Overall response rate was 51.5% (95%CI 41.8-61.2) (4 complete responses), clinical benefit rate 85.2% (78.3-92.1), median progression free survival (PFS) 6.1 months (m) (5.4-6.8) and 6 m PFS 50.2% (40.4-60.0). Notable differences were found in PFS according number of EP+D cycles received: ≤4 cycles: 5.4m (4.1-6.1), >4 cycles: 6.9m (5.8-10.6), p=0.010. Most frequent adverse events ≥G3 were: anemia (22%), neutropenia (20%), thrombocytopenia (6%) and hyponatremia (5%).
Conclusions
CANTABRICO median PFS and safety profile appeared consistent with that seen in the Phase 3 CASPIAN study, providing real-world evidence to support D+EP as a standard of care in ES-SCLC.
Clinical trial identification
NCT04712903; EudraCT 2020-002328-35.
Editorial acknowledgement
AstraZeneca thanks Juan Luis Sanz (APICES, Spain) for his editorial assistance.
Legal entity responsible for the study
AstraZeneca Farmacéutica Spain, S.A.
Funding
AstraZeneca Farmacéutica Spain, S.A.
Disclosure
D. Isla: Non-Financial Interests, Personal, Invited Speaker: AstraZeneca; Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca. E. Arriola: Financial Interests, Personal and Institutional, Advisory Board: Roche, BMS, AstraZeneca; Financial Interests, Personal and Institutional, Invited Speaker: Roche, AstraZeneca, BMS; Financial Interests, Personal and Institutional, Funding: Roche, AstraZeneca, BMS; Financial Interests, Personal, Advisory Board: MSD, Lilly, Takeda; Financial Interests, Personal, Invited Speaker: MSD, Lilly, Takeda, Pfizer. M.R. Garcia Campelo: Financial Interests, Personal, Advisory Board: MSD, BMS, Roche, Boehringer Ingelheim, Medscape Pfizer, Novartis, AstraZeneca, Lilly, Takeda; Financial Interests, Personal, Invited Speaker: MSD, BMS, Roche, Boehringer Ingelheim, Medscape Pfizer, Novartis, AstraZeneca, Lilly, Takeda; Financial Interests, Personal, Other: MSD, BMS, Roche, Boehringer Ingelheim, Medscape, Pfizer, Novartis, AstraZeneca, Lilly, Takeda. P. Diz Tain: Financial Interests, Personal, Invited Speaker: BMS, Boehringer Ingelheim, MSD, Takeda, Pfizer, Amgen; Financial Interests, Personal, Advisory Board: BMS, Boehringer Ingelheim, MSD, Takeda; Financial Interests, Personal, Training: BMS, Boehringer Ingelheim, MSD, Takeda, Pfizer; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Roche; Financial Interests, Personal and Institutional, Advisory Board: AstraZeneca, Roche; Financial Interests, Personal and Institutional, Training: AstraZeneca, Roche; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca, Roche; Financial Interests, Institutional, Principal Investigator: Mirati. C. Marti Blanco: Financial Interests, Personal, Writing Engagements: AstraZeneca; Financial Interests, Personal, Invited Speaker: MSD; Non-Financial Interests, Institutional, Sponsor/Funding: BMS, Meck. A.L. Moreno Vega: Non-Financial Interests, Personal and Institutional, Invited Speaker: PharmaMar, Pfizer. L.A. Leon Mateos: Financial Interests, Personal, Advisory Board: Pfizer, Boehringer, Novartis, AstraZeneca, Bristol, MSD; Financial Interests, Personal, Expert Testimony: Sanofi; Financial Interests, Personal and Institutional, Other: MSD. J.M. Oramas Rodriguez: Non-Financial Interests, Institutional, Principal Investigator: HUC. M. Majem Tarruella: Financial Interests, Personal, Speaker’s Bureau: Sanofi, Pfizer, Janssen, Bristol Myers Squibb, MSD, Boehringer-Ingelheim, AstraZeneca, Roche, Kyowa Kyrin, Pierre Fabre, Takeda, Bayer; Financial Interests, Personal, Advisory Board: Sanofi, Pfizer, Janssen, Bristol Myers Squibb, MSD, Boehringer Ingelheim, AstraZeneca, Roche, Kyowa Kyrin, Pierre Fabre, Takeda, Bayer; Financial Interests, Personal, Research Grant: Bristol Myers Squibb. A. Sanchez Hernandez: Financial Interests, Personal and Institutional, Invited Speaker: MSD, Roche; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Financial Interests, Personal, Other: Sanofi, Takeda; Financial Interests, Personal, Advisory Board: Sanofi, Lilly; Financial Interests, Personal and Institutional, Other: Pfizer; Financial Interests, Personal, Expert Testimony: Novartis. C. Aguado de la Rosa: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, BMS, Roche, Pfizer; Financial Interests, Personal, Principal Investigator: AstraZeneca, MSD; Financial Interests, Personal, Advisory Board: BMS, Sanofi; Non-Financial Interests, Institutional, Principal Investigator: Mirati, Lilly. A. Moreno Paul: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Ipsen; Non-Financial Interests, Personal, Other: MSD. Á. Callejo Mellén: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. L. Baez: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. L. Paz-Ares: Financial Interests, Institutional, Research Grant: MSD, AstraZeneca, Pfizer, BMS; Financial Interests, Personal, Licensing Fees: Lilly, MSD, Roche, PharmaMar, Merck, AstraZeneca, Novartis, Servier, Amgen, Pfizer, Sanofi, Bayer, BMS, Mirati, GSK, Janssen, Takeda; Financial Interests, Personal, Other: AstraZeneca, Janssen, Merck, Mirati; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Janssen, Merck, Mirati. All other authors have declared no conflicts of interest.