Correlation between overall survival and growth modulation index in pre-treated sarcoma patients: A study from the French Sarcoma Group

Annals of Oncology

Volumn 24, Issue 10, 2013, Pages 2681-2685

  Cousin, S ^a   Blay, J Y ^b   Bertucci, F ^c   Isambert, N ^d   Italiano, A ^e   Bompas, E ^f   Ray Coquard, I ^b   Perrot, D ^c   Chaix, M ^d   Bui Nguyen, B ^e   Chaigneau, L ^g   Corradini, N ^h   Penel, N ^a,i  

^a CENTRE OSCAR LAMBRET   (France)

^b CENTRE LÉON BÉRARD   (France)

^c INSTITUT PAOLI CALMETTES   (France)

^d Biostatistic and Quality of Life Unit Georges François Leclerc Center   (France)

^e INSTITUT BERGONIÉ   (France)

^f René Gauducheau Center   (France)

^g UNIVERSITY HOSPITAL JEAN MINJOZ   (France)

^h NANTES UNIVERSITY HOSPITAL   (France)

ⁱ UNIV LILLE   (France)

Author keywords

End point; Growth modulation index; Soft tissue sarcoma; Time to progression

Indexed keywords

DACARBAZINE; DOXORUBICIN; GEMCITABINE; IFOSFAMIDE; PACLITAXEL; TRABECTEDIN;

ADULT; AGED; ANGIOSARCOMA; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CHILD; CONTROLLED STUDY; CORRELATIONAL STUDY; FEMALE; FRANCE; HUMAN; LEIOMYOSARCOMA; LIPOSARCOMA; MAJOR CLINICAL STUDY; MALE; OVERALL SURVIVAL; PREDICTION; PRESCHOOL CHILD; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RETROSPECTIVE STUDY; SOFT TISSUE SARCOMA; SURVIVAL RATE; SURVIVAL TIME; SYNOVIAL SARCOMA; TREATMENT DURATION;

END POINT; GROWTH MODULATION INDEX; SOFT TISSUE SARCOMA; TIME TO PROGRESSION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIBIOTICS, ANTINEOPLASTIC; CHILD; CHILD, PRESCHOOL; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; HUMANS; INFANT; MALE; MIDDLE AGED; RETROSPECTIVE STUDIES; SARCOMA; SOFT TISSUE NEOPLASMS; SURVIVAL; SURVIVAL RATE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84884713267     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt278     Document Type: Article

References (28)

1. Ducimetière F, Lurkin A, Ranchère-Vince D et al. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS ONE 2011; 6: e20294.
2. Clark MA, Fisher C, Judson I et al. Soft-tissue sarcomas in adults. N Engl J Med 2005; 353: 701-711.
3. Verweij J, Mouridsen HT, Nielssen OS et al. The present state of the art in chemotherapy for soft tissue sarcomas in adults: the EORTC point of view. Crit Rev Oncol Hematol 1995; 20: 193-201.
4. Sleijfer S, Seynaeve C, Verweij J. Using single-agent therapy in adult patients with advanced soft tissue sarcoma can still be considered standard care. Oncologist 2005; 10: 833-841.
5. Penel N, Van Glabbeke M, Mathoulin-Pelissier S et al. Performance status is the most powerful risk factor for early death among patients with advanced soft tissue sarcoma. The european organisation for research and treatment of cancer - soft tissue and bone sarcoma group (STBSG) and french sarcoma group (FSG) study. Br J Cancer 2011; 104: 1544-1550.
6. Demetri GD, Chawla SP, von Mehren M et al. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol 2009; 27: 4188-4196.
7. Pautier P, Floquet A, Penel N et al. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a federation nationale des centres de lutte contre le cancer (FNCLCC) french sarcoma group study (TAXOGEM study). Oncologist 2012; 17: 1213-1220.
8. Sleijfer S, Ray-Coquard I, Papai Z et al. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the european organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol 2009; 27: 3126-3132.
9. Van Der Graaf WTA, Blay J-Y, Chawla SP et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2012; 379: 1879-1886.
10. Schöffski P, Ray-Coquard IL, CioffiA et al. Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol 2011; 12: 1045-1052.
11. Leahy M, Ray-Coquard I, Verweij J et al. Brostallicin, an agent with potential activity in metastatic soft tissue sarcoma: a phase II study from the european organisation for research and treatment of cancer soft tissue and bone sarcoma group. Eur J Cancer 2007; 43: 308-315.
12. Garcia del Muro X, Lopez-Pousa A, Martin J et al. A phase II trial of temozolomide as a 6-week, continuous, oral schedule in patients with advanced soft tissue sarcoma: a study by the spanish group for research on sarcomas. Cancer 2005; 104: 1706-1712.
13. Penel N, Van Glabbeke M, Marreaud S et al. Testing new regimes in patients with advanced soft tissue sarcoma: analysis of publications from the last 10 years. Ann Oncol 2011; 22: 1266-1272.
14. Simon R, Thall PF, Ellenberg SS. New designs for the selection of treatments to be tested in randomized clinical trials. Stat Med 1994; 13: 1375-1381.
15. Rubinstein LV, Korn EL, Freidlin B et al. Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 2005; 23: 7199-7206.
16. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-247.
17. Von HoffDD. There are no bad anticancer agents, only bad clinical trial designtwenty- first richard and hinda rosenthal foundation award lecture. Clin Cancer Res 1998; 4: 1079-1086.
18. Mick R, Crowley JJ, Carroll RJ. Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. Contr Clin Trials 2000; 21: 343-359.
19. Kovalchik S, Mietlowski W. Statistical methods for a phase II oncology trial with growth modulation index (GMI) endpoint. Contemp Clin Trials 2011; 32: 99-107.
20. Cousin S, Taieb S, Penel N. A paradigm shift in tumour response evaluation of targeted therapy: the assessment of novel drugs in exploratory clinical trials. Curr Opin Oncol 2012; 24: 338-344.
21. Van Gabbeke M, Verweij J, Judson I et al. Progression-free rate as the primary endpoint for phase II study in soft tissue sarcoma. Eur J Cancer 2002; 38: 543-549.
22. Bonetti A, Zaninelli M, Leone R et al. Use of the ratio of time to progression following first- and second-line therapy to document the activity of the combination of oxaliplatin with 5-fluorouracil in the treatment of colorectal carcinoma. Ann Oncol 2011; 12: 187-191.
23. Von HoffDD, Stephenson JJ, Jr, Rosen P et al. Pilot study using molecular profiling of patient's tumors to find potential targets and select treatments for their refractory cancers. J Clin Oncol 2010; 28: 4877-4883.
24. Comella P, Casaretti R, Crucitta E et al. Oxaliplatin plus raltitrexed and leucovorinmodulated 5-fluorouracil i.v. bolus: a salvage regimen for colorectal cancer patients. Br J Cancer 2002; 86: 1871-1875.
25. Zalcberg JR, Verweij J, Casali PG et al. Outcome of patients with advanced gastrointestinal stromal tumours crossing over to a daily imatinib dose of 800 mg after progression on 400 mg. Eur J Cancer 2005; 41: 1751-1757.
26. Tournigand C, André T, Achille E et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 2004; 22: 229-237.
27. Penel N, Demetri GD, Blay JY et al. Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as salvage therapy. Ann Oncol 2013; 24: 537-542.
28. Buyse M, Quinaux E, Hendlisz A et al. Progression-free survival ratio as endpoint for phase II trials in adadvanced solid tumors. J Clin Oncol 2011; 29: e451-e452.