User menu

Accès à distance ? S'identifier sur le proxy UCLouvain

Association of progression-free survival with patient-reported outcomes and survival : results from a randomised phase 3 trial of panitumumab.

Primary tabs

download
  • Open access
  • PDF
  • 176.25 K
Siena, S. Peeters, M. Van Cutsem, Eric [KUL] Humblet, Yves [UCL] Conte, P. Amado, R.G.

In a randomised phase 3 trial, panitumumab significantly improved progression-free survival (PFS) in patients with refractory metastatic colorectal cancer (mCRC). This analysis characterises the association of PFS with CRC symptoms, health-related quality of life (HRQoL), and overall survival (OS). CRC symptoms (NCCN/FACT CRC symptom index, FCSI) and HRQoL (EQ-5D) were assessed for 207 panitumumab patients and 184 best supportive care (BSC) patients who had at least one post-baseline patient-reported outcome (PRO) assessment. Patients alive at week 8 were included in the PRO and OS analyses and categorised by their week 8 progression status as follows: no progressive disease (no PD; best response of at least stable disease) vs progressive disease (PD). Standard imputation methods were used to assign missing values. Significantly more patients were progression free at weeks 8-24 with panitumumab vs BSC. After excluding responders, a significant difference in PFS remained favouring panitumumab (HR=0.63, 95% CI=0.52-0.77; P<0.0001). At week 8, lack of disease progression was associated with significantly and clinically meaningful lower CRC symptomatology for both treatment groups and higher HRQoL for panitumumab patients only. Overall survival favoured no PD patients vs PD patients alive at week 8. Lack of disease progression was associated with better symptom control, HRQoL, and OS.

Document type Article de périodique (Journal article) – Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
Access type Accès libre
Publication date 2007
Language Anglais
Journal information "The British journal of cancer" - Vol. 97, no. 11, p. 1469-74 (2007)
Peer reviewed yes
Publisher Nature Publishing Group ((United Kingdom) London)
issn 0007-0920
e-issn 1532-1827
Publication status Publié
Affiliations UCL - MD/MINT - Département de médecine interne
UCL - (SLuc) Unité d'oncologie médicale
MESH Subject Antibodies, Monoclonal - immunology, therapeutic use ; Colorectal Neoplasms - drug therapy, pathology ; Severity of Illness Index ; Survival Analysis ; Treatment Outcome ; Disease Progression ; Drug Administration Schedule ; Drug Resistance, Neoplasm ; Humans ; Neoplasm Metastasis ; Quality of Life ; Receptor, Epidermal Growth Factor ; Self-Examination
Links
  1. Aaronson N. K., Ahmedzai S., Bergman B., Bullinger M., Cull A., Duez N. J., Filiberti A., Flechtner H., Fleishman S. B., Haes J. C. J. M. d., Kaasa S., Klee M., Osoba D., Razavi D., Rofe P. B., Schraub S., Sneeuw K., Sullivan M., Takeda F., The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in Oncology, 10.1093/jnci/85.5.365
  2. Benvenuti S., Sartore-Bianchi A., Di Nicolantonio F., Zanon C., Moroni M., Veronese S., Siena S., Bardelli A., Oncogenic Activation of the RAS/RAF Signaling Pathway Impairs the Response of Metastatic Colorectal Cancers to Anti-Epidermal Growth Factor Receptor Antibody Therapies, 10.1158/0008-5472.can-06-4158
  3. Cella David, Paul Diane, Yount Susan, Winn Rodger, Chang Chih-Hung, Banik Donald, Weeks Jane, What Are the Most Important Symptom Targets When Treating Advanced Cancer? A Survey of Providers in the National Comprehensive Cancer Network (NCCN) : ORIGINAL ARTICLE, 10.1081/cnv-120022366
  4. Cunningham David, Humblet Yves, Siena Salvatore, Khayat David, Bleiberg Harry, Santoro Armando, Bets Danny, Mueser Matthias, Harstrick Andreas, Verslype Chris, Chau Ian, Van Cutsem Eric, Cetuximab Monotherapy and Cetuximab plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal Cancer, 10.1056/nejmoa033025
  5. de Gramont A, J Clin Oncol, 18, 2938 (2000)
  6. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P, Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial, 10.1016/s0140-6736(00)02034-1
  7. Escudier Bernard, Eisen Tim, Stadler Walter M., Szczylik Cezary, Oudard Stéphane, Siebels Michael, Negrier Sylvie, Chevreau Christine, Solska Ewa, Desai Apurva A., Rolland Frédéric, Demkow Tomasz, Hutson Thomas E., Gore Martin, Freeman Scott, Schwartz Brian, Shan Minghua, Simantov Ronit, Bukowski Ronald M., Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma, 10.1056/nejmoa060655
  8. Fielding S, Fayers P M, Loge J H, Jordhøy M S, Kaasa S, Methods for handling missing data in palliative care research, 10.1177/0269216306072555
  9. Foon Kenneth A, Yang Xiao-Dong, Weiner Louis M, Belldegrun Arie S, Figlin Robert A, Crawford Jeffrey, Rowinsky Eric K, Dutcher Janice P, Vogelzang Nicholas J, Gollub Jared, Thompson John A, Schwartz Garry, Bukowski Ronald M, Roskos Lorin K, Schwab Gisela M, Preclinical and clinical evaluations of ABX-EGF, a fully human anti-epidermal growth factor receptor antibody, 10.1016/j.ijrobp.2003.09.098
  10. Hurwitz Herbert, Fehrenbacher Louis, Novotny William, Cartwright Thomas, Hainsworth John, Heim William, Berlin Jordan, Baron Ari, Griffing Susan, Holmgren Eric, Ferrara Napoleone, Fyfe Gwen, Rogers Beth, Ross Robert, Kabbinavar Fairooz, Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer, 10.1056/nejmoa032691
  11. Lièvre Astrid, Bachet Jean-Baptiste, Le Corre Delphine, Boige Valérie, Landi Bruno, Emile Jean-François, Côté Jean-François, Tomasic Gorana, Penna Christophe, Ducreux Michel, Rougier Philippe, Penault-Llorca Frédérique, Laurent-Puig Pierre, KRASMutation Status Is Predictive of Response to Cetuximab Therapy in Colorectal Cancer, 10.1158/0008-5472.can-06-0191
  12. Louvet Christophe, de Gramont Aimery, Tournigand Christophe, Artru Pascal, Maindrault-Goebel Fr�d�rique, Krulik Marcel, Correlation between progression free survival and response rate in patients with metastatic colorectal carcinoma, 10.1002/1097-0142(20010601)91:11<2033::aid-cncr1229>3.0.co;2-j
  13. Moroni Mauro, Veronese Silvio, Benvenuti Silvia, Marrapese Giovanna, Sartore-Bianchi Andrea, Di Nicolantonio Federica, Gambacorta Marcello, Siena Salvatore, Bardelli Alberto, Gene copy number for epidermal growth factor receptor (EGFR) and clinical response to antiEGFR treatment in colorectal cancer: a cohort study, 10.1016/s1470-2045(05)70102-9
  14. Osoba D, J Clin Oncol, 16, 139 (1998)
  15. Parkin DM, CA Cancer J Clin, 55, 74 (2005)
  16. Ratain Mark J., Eisen Tim, Stadler Walter M., Flaherty Keith T., Kaye Stan B., Rosner Gary L., Gore Martin, Desai Apurva A., Patnaik Amita, Xiong Henry Q., Rowinsky Eric, Abbruzzese James L., Xia Chenghua, Simantov Ronit, Schwartz Brian, O'Dwyer Peter J., Phase II Placebo-Controlled Randomized Discontinuation Trial of Sorafenib in Patients With Metastatic Renal Cell Carcinoma, 10.1200/jco.2005.03.6723
  17. Rothenberg Mace L., Oza Amit M., Bigelow Robert H., Berlin Jordan D., Marshall John L., Ramanathan Ramesh K., Hart Lowell L., Gupta Sunil, Garay Carlos A., Burger Brent G., Le Bail Nathalie, Haller Daniel G., Superiority of Oxaliplatin and Fluorouracil-Leucovorin Compared With Either Therapy Alone in Patients With Progressive Colorectal Cancer After Irinotecan and Fluorouracil-Leucovorin: Interim Results of a Phase III Trial, 10.1200/jco.2003.11.126
  18. Saltz Leonard B., Cox John V., Blanke Charles, Rosen Lee S., Fehrenbacher Louis, Moore Malcolm J., Maroun Jean A., Ackland Stephen P., Locker Paula K., Pirotta Nicoletta, Elfring Gary L., Miller Langdon L., Irinotecan plus Fluorouracil and Leucovorin for Metastatic Colorectal Cancer, 10.1056/nejm200009283431302
  19. Saltz Leonard B., Meropol Neal J., Loehrer Patrick J., Needle Michael N., Kopit Justin, Mayer Robert J., Phase II Trial of Cetuximab in Patients With Refractory Colorectal Cancer That Expresses the Epidermal Growth Factor Receptor, 10.1200/jco.2004.10.182
  20. Sartore-Bianchi Andrea, Moroni Mauro, Veronese Silvio, Carnaghi Carlo, Bajetta Emilio, Luppi Gabriele, Sobrero Alberto, Barone Carlo, Cascinu Stefano, Colucci Giuseppe, Cortesi Enrico, Nichelatti Michele, Gambacorta Marcello, Siena Salvatore, Epidermal Growth Factor Receptor Gene Copy Number and Clinical Outcome of Metastatic Colorectal Cancer Treated With Panitumumab, 10.1200/jco.2007.11.5956
  21. Therasse Patrick, Arbuck Susan G., Eisenhauer Elizabeth A., Wanders Jantien, Kaplan Richard S., Rubinstein Larry, Verweij Jaap, Van Glabbeke Martine, van Oosterom Allan T., Christian Michaele C., Gwyther Steve G., New Guidelines to Evaluate the Response to Treatment in Solid Tumors, 10.1093/jnci/92.3.205
  22. Tournigand Christophe, André Thierry, Achille Emmanuel, Lledo Gérard, Flesh Michel, Mery-Mignard Dominique, Quinaux Emmanuel, Couteau Corinne, Buyse Marc, Ganem Gérard, Landi Bruno, Colin Philippe, Louvet Christophe, de Gramont Aimery, FOLFIRI Followed by FOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer: A Randomized GERCOR Study, 10.1200/jco.2004.05.113
  23. Van Cutsem Eric, Peeters Marc, Siena Salvatore, Humblet Yves, Hendlisz Alain, Neyns Bart, Canon Jean-Luc, Van Laethem Jean-Luc, Maurel Joan, Richardson Gary, Wolf Michael, Amado Rafael G., Open-Label Phase III Trial of Panitumumab Plus Best Supportive Care Compared With Best Supportive Care Alone in Patients With Chemotherapy-Refractory Metastatic Colorectal Cancer, 10.1200/jco.2006.08.1620
  24. Walters Stephen J., Brazier John E., Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D, 10.1007/s11136-004-7713-0
  25. Yang XD, Cancer Res, 59, 1236 (1999)
  26. Yarden Yosef, Sliwkowski Mark X., 10.1038/35052073
Bibliographic reference Siena, S. ; Peeters, M. ; Van Cutsem, Eric ; Humblet, Yves ; Conte, P. ; et. al. Association of progression-free survival with patient-reported outcomes and survival : results from a randomised phase 3 trial of panitumumab.. In: The British journal of cancer, Vol. 97, no. 11, p. 1469-74 (2007)
Permanent URL http://hdl.handle.net/2078.1/86721