Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial
Por:
Palmerini, E, Pousa, AL, Grignani, G, Redondo, A, Hindi, N, Provenzano, S, Sebio, A, Martin, JAL, Valverde, C, Trufero, JM, Gutierrez, A, de Alava, E, Gomez, MPA, D'Ambrosio, L, Collini, P, Bazzocchi, A, Moura, DS, Ibrahim, T, Stacchiotti, S, Broto, JM
Publicada:
1 ene 2025
Ahead of Print:
1 nov 2024
Resumen:
Background: Herein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS). Methods: Progressing patients with a diagnosis of BS were eligible. Treatment was comprised of sunitinib (37.5 mg/day on days 1-14, 25 mg/day afterword) plus nivolumab (3 mg/kg every 2 weeks). Primary end point was progression-free survival rate (PFSR) at 6 months based on central radiology review. Secondary end points were overall survival (OS), overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and safety. Results: A total of 46 patients were screened, 40 patients entered the study, and 38 underwent central radiological review and were evaluable for primary end point. Median age was 47 years (range, 21-74). Histologies include 17 (43%) osteosarcoma, 14 chondrosarcoma (35%, 10 conventional, four dedifferentiated [DDCS]), eight (20%) Ewing sarcoma, and one (2%) undifferentiated pleomorphic sarcoma. The PFSR at 6 months was 42% (95% confidence interval [CI], 27-58). With a median follow-up of 39.8 months (95% CI, 37.9-41.7), the median PFS and OS were 3.8 months (95% CI, 2.7-4.8) and 11.9 months (95% CI, 5.6-18.2). ORR by RECIST was 5%, with two of 38 partial responses (one of four DDCS and one of 17 osteosarcoma), 19 of 38 (50%) stable disease, and 17 of 38 (45%) progressions. Grade >= 3 adverse events were neutropenia (six of 40, 15%), anemia (5/40, hypertension (6/40, 15%), 12.5%), ALT/AST elevation (5/40, 12.5%), and pneumonitis (1/40, 2.5%). Seventeen percent of patients discontinued treatment due to toxicity, including a treatment-related grade 5 pneumonitis Conclusion: The trial met its primary end point in the BS cohort with >15% of patients progression-free at 6 months. However, the toxicity profile of this regimen was relevant.
Filiaciones:
Palmerini, E:
IRCCS Ist Ortoped Rizzoli, Osteoncol Bone & Soft Tissue Tumors & Innovat Ther, Via Pupilli 1, I-40136 Bologna, Italy
Pousa, AL:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Grignani, G:
FPO IRCCS, Candiolo Canc Inst, Candiolo, TO, Italy
Redondo, A:
Hosp Univ La Paz, Med Oncol Dept, IdiPAZ, Madrid, Spain
Hindi, N:
Univ Hosp Fdn Jimenez Diaz, Med Oncol Dept, Madrid, Spain
Hosp Gen Villalba, Madrid, Spain
Inst Invest Sanitaria Fdn Jimenez Diaz, Madrid, Spain
Provenzano, S:
Fdn IRCCS Ist Nazl Tumori, Dept Surg, Milan, Milan, Italy
Sebio, A:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Martin, JAL:
Hosp Univ 12 Octubre, Madrid, Spain
Valverde, C:
Hosp Univ Vall dHebron, Barcelona, Spain
Trufero, JM:
Hosp Univ Miguel Servet, Zaragoza, Spain
Gutierrez, A:
Hosp Univ Son Espases, Palma De Mallorca, Spain
de Alava, E:
Univ Seville, Virgen Rocio Univ Hosp, Inst Biomed Sevilla IBiS, CSIC,CIBERONC, Seville 41013, Spain
Univ Seville, Sch Med, Dept Normal & Pathol Cytol & Histol, Seville, Spain
Gomez, MPA:
Auckland Dist Hlth Board, Auckland City Hosp, Dept Radiol, Auckland, New Zealand
IMSKE, Dept Radiol, Valencia, Spain
D'Ambrosio, L:
FPO IRCCS, Candiolo Canc Inst, Candiolo, TO, Italy
Univ Turin, Dept Oncol, Turin, Italy
Collini, P:
Fdn IRCCS Ist Nazl Tumori, Adv Diagnost Dept, Soft Tissue Tumor Pathol Unit, Milan, Italy
Bazzocchi, A:
IRCCS Ist Ortoped Rizzoli, Diagnost & Intervent Radiol, Bologna, Italy
Moura, DS:
Inst Invest Sanitaria Fdn Jimenez Diaz, Med Oncol Dept, Madrid, Spain
Ibrahim, T:
IRCCS Ist Ortoped Rizzoli, Osteoncol Bone & Soft Tissue Tumors & Innovat Ther, Via Pupilli 1, I-40136 Bologna, Italy
Stacchiotti, S:
Fdn IRCCS Ist Nazl Tumori, Dept Surg, Milan, Milan, Italy
Broto, JM:
Univ Hosp Fdn Jimenez Diaz, Med Oncol Dept, Madrid, Spain
Hosp Gen Villalba, Madrid, Spain
Inst Invest Sanitaria Fdn Jimenez Diaz, Madrid, Spain
Green Accepted, Green Submitted, hybrid
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