Rachel P Riechelmann1, Vichien Srimuninnimit2, Roberto Bordonaro3, Petr Kavan4, Maria Di Bartolomeo5, Evaristo Maiello6, Irfan Cicin7, Pilar García-Alfonso8, Ian Chau9, Mikhail Y Fedyanin10, Carlos Fernández Martos11, Mikhail Ter-Ovanesov12, Marc Peeters13, Yoo-Joung Ko14, Suayib Yalcin15, Meinolf Karthaus16, Jorge Aparicio17, Volker Heinemann18, Pascaline Picard19, Denise Bury20, Edward Drea20, Alberto Sobrero21. 1. Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil; Department of Clinical Oncology, AC Camargo Cancer Center, São Paulo, Brazil. Electronic address: Rachel.riechelmann@accamargo.org.br. 2. Ramathibodi Hospital, Siriraj Hospital, Bangkok, Thailand. 3. Department of Oncology, Garibaldi Nesima Hospital, Catania, Italy. 4. Gerald Bronfman Department of Oncology, McGill University, Segal Cancer Centre, Jewish General Hospital, Montreal, Quebec, Canada. 5. Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy. 6. IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 7. Division of Medical Oncology, Department of Internal Medicine, Balkan Oncology Hospital, Trakya University, Edirne, Turkey. 8. Department of Medical Oncology, Hospital Universitario Gregorio Marañón de Madrid, Madrid, Spain. 9. Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom. 10. Department of Clinical Pharmacology and Chemotherapy, N.N. Blokhin National Medical Research Center of Oncology, Moscow, Russia. 11. Department of Medical Oncology, Instituto Valenciano de Oncología, Valencia, Spain. 12. Thoraco-abdominal Oncosurgical Department, Clinical Central Hospital of the Presidential Administration of the Russian Federation, Moscow, Russia. 13. Department of Oncology, Antwerp University Hospital, Edegem, Belgium. 14. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada. 15. Department of Medical Oncology, Cancer Institute, Hacettepe University, Ankara, Turkey. 16. Klinikum Neuperlach, Städtisches Klinikum München, Munich, Germany. 17. Hospital Universitario y Politécnico de La Fe, Valencia, Spain. 18. Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, Ludwig Maximilian University of Munich, Munich, Germany. 19. Sanofi (contracted by Ividata-Stats), Paris, France. 20. Sanofi (contracted by Artech Information Systems LLC), Cambridge, MA. 21. IRCCS Azienda Ospedaliera Universitaria San Martino, Genova, Italy.
Abstract
BACKGROUND: The objectives of this study were to evaluate the safety profile of aflibercept and health-related quality of life (HRQL) in patients with metastatic colorectal cancer (mCRC) provided with aflibercept access before marketing authorization. PATIENTS AND METHODS: Patients received aflibercept followed by FOLFIRI (fluorouracil, leucovorin, irinotecan) on day 1 of a 2-week cycle until disease progression, unacceptable toxicity, death, or patient/investigator decision to discontinue. Treatment-emergent adverse events (TEAEs) were evaluated, and HRQL was assessed at baseline, cycle 3, and every other cycle using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-CR29, and EuroQol 5-Dimensions 3-Levels questionnaires (NCT01571284). RESULTS: Overall, 779 adult patients with mCRC, who received ≥ 1 prior oxaliplatin-based regimen and had disease progression during or following their last administration of oxaliplatin-based chemotherapy, were enrolled. At data cutoff, all patients had discontinued treatment, mainly owing to disease progression (51.7%). The most common TEAEs of any grade were diarrhea (61.6%), hypertension (48.4%), and nausea (43.3%). The most common grade 3/4 TEAEs were hypertension (24.1%), neutropenia (23.1%), and diarrhea (15.3%). Clinically meaningful changes in HRQL were reported for all measures. Most patients either had an improvement in their HRQL scores or remained stable during the treatment period based on patient-reported outcomes. CONCLUSION: The data from this study support the tolerability of the combination of aflibercept and FOLFIRI in a setting that more closely approximates real life in patients with mCRC who failed to respond to oxaliplatin-based chemotherapy, and also suggest an improvement in HRQL.
BACKGROUND: The objectives of this study were to evaluate the safety profile of aflibercept and health-related quality of life (HRQL) in patients with metastatic colorectal cancer (mCRC) provided with aflibercept access before marketing authorization. PATIENTS AND METHODS: Patients received aflibercept followed by FOLFIRI (fluorouracil, leucovorin, irinotecan) on day 1 of a 2-week cycle until disease progression, unacceptable toxicity, death, or patient/investigator decision to discontinue. Treatment-emergent adverse events (TEAEs) were evaluated, and HRQL was assessed at baseline, cycle 3, and every other cycle using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-CR29, and EuroQol 5-Dimensions 3-Levels questionnaires (NCT01571284). RESULTS: Overall, 779 adult patients with mCRC, who received ≥ 1 prior oxaliplatin-based regimen and had disease progression during or following their last administration of oxaliplatin-based chemotherapy, were enrolled. At data cutoff, all patients had discontinued treatment, mainly owing to disease progression (51.7%). The most common TEAEs of any grade were diarrhea (61.6%), hypertension (48.4%), and nausea (43.3%). The most common grade 3/4 TEAEs were hypertension (24.1%), neutropenia (23.1%), and diarrhea (15.3%). Clinically meaningful changes in HRQL were reported for all measures. Most patients either had an improvement in their HRQL scores or remained stable during the treatment period based on patient-reported outcomes. CONCLUSION: The data from this study support the tolerability of the combination of aflibercept and FOLFIRI in a setting that more closely approximates real life in patients with mCRC who failed to respond to oxaliplatin-based chemotherapy, and also suggest an improvement in HRQL.
Authors: Seung-Hoon Beom; Jong Gwang Kim; Seung Hyuk Baik; Seong Hoon Shin; Inkeun Park; Young Suk Park; Myung-Ah Lee; Soohyeon Lee; So-Yeon Jeon; Sae-Won Han; Myoung Hee Kang; Jisu Oh; Jin Soo Kim; Jin Young Kim; Mi Sun Ahn; Dae Young Zang; Byung-Noe Bae; Hong Jae Jo; Hee Kyung Kim; Jung-Han Kim; Ji Ae Yoon; Dong Han Kim Journal: J Cancer Res Clin Oncol Date: 2022-03-27 Impact factor: 4.553
Authors: S Kopetz; A Grothey; E Van Cutsem; R Yaeger; H Wasan; T Yoshino; J Desai; F Ciardiello; F Loupakis; Y S Hong; N Steeghs; T K Guren; H-T Arkenau; P Garcia-Alfonso; A Belani; X Zhang; J Tabernero Journal: ESMO Open Date: 2022-05-30