Randomized phase II study comparing gemcitabine plus dacarbazine versus dacarbazine alone in patients with previously treated soft tissue sarcoma: A Spanish group for research on sarcomas study

Journal of Clinical Oncology

Volumn 29, Issue 18, 2011, Pages 2528-2533

  García del Muro, Xavier ^a   López Pousa, Antonio ^b   Maurel, Joan ^c   Martín, Javier ^d   Martínez Trufero, Javier ^e   Casado, Antonio ^g   Gómez España, Auxiliadora ⁱ   Fra, Joaquín ^j   Cruz, Josefina ^k   Poveda, Andrés ^l   Meana, Andrés ^m   Pericay, Carlos ⁿ   Cubedo, Ricardo ^h   Rubió, Jordi ^o   De Juan, Ana ^p   Laínez, Nuria ^q   Carrasco, Juan Antonio ^r   De Andrés, Raquel ^f   Buesa, José M ^j  

^a BELLVITGE BIOMEDICAL RESEARCH INSTITUTE IDIBELL   (Spain)

^b Hospital Sant Pau   (Spain)

^c HOSPITAL CLÍNIC   (Spain)

^d HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^e HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^f HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^g HOSPITAL CLÍNICO SAN CARLOS   (Spain)

^h HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

ⁱ HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^j HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

^k HOSPITAL UNIVERSITARIO DE CANARIAS   (Spain)

^l INSTITUTO VALENCIANO DE ONCOLOGÍA   (Spain)

^m HOSPITAL GENERAL UNIVERSITARIO DE ALICANTE   (Spain)

ⁿ HOSPITAL DE SABADELL   (Spain)

^o CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^p HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^q Universidad Pública de Navarra   (Spain)

^r Hospital Xral Cies   (Spain)

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Author keywords

[No Author keywords available]

Indexed keywords

DACARBAZINE; GEMCITABINE;

ADOLESCENT; ADULT; ALOPECIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; GRANULOCYTOPENIA; HUMAN; LEUKOPENIA; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; ONCOLOGICAL PARAMETERS; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE RATE; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SOFT TISSUE SARCOMA; STOMATITIS; TREATMENT OUTCOME; VOMITING;

EID: 79959300987     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2010.33.6107     Document Type: Article

References (17)

1. Weitz J, Antonescu CR, Brennan MF: Localized extremity soft tissue sarcoma: Improved knowledge with unchanged survival over time. J Clin Oncol 21:2719-2725, 2003 (Pubitemid 46606317)
2. Van Glabbeke M, van Oosterom AT, Oosterhuis JW, et al: Prognostic factors for the outcome of chemotherapy in advanced soft tissue sarcoma: An analysis of 2,185 patients treated with anthracycline-containing first-line regimens - A European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. J Clin Oncol 17:150-157, 1999 (Pubitemid 29022388)
3. Sleijfer S, Ouali M, van Glabbeke M, et al: Prognostic and predictive factors for outcome to firstline ifosfamide-containing chemotherapy for adult patients with advanced soft tissue sarcomas: An exploratory, retrospective analysis on large series from the European Organization for Research and Treatment of Cancer-Soft Tissue and Bone Sarcoma Group (EORTC-STBSG). Eur J Cancer 46:72-83, 2010
4. Buesa JM, Mouridsen HT, van Oosterom AT, et al: High-dose DTIC in advanced soft-tissue sarcomas in the adult. A phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. Ann Oncol 2:307-309, 1991
5. Maurel J, Ló pez-Pousa A, de Las Peñas R, et al: Efficacy of sequential high-dose doxorubicin and ifosfamide compared with standard-dose doxorubicin in patients with advanced soft tissue sarcoma: An open-label randomized phase II study of the Spanish Group for Research on Sarcomas. J Clin Oncol 27:1893-1898, 2009
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 27:4188-4196, 2009
7. 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 104:1706-1712, 2005 (Pubitemid 41437435)
8. Patel SR, Gandhi V, Jenkins J, et al: Phase II clinical investigation of gemcitabine in advanced soft tissue sarcomas and window evaluation of dose rate on gemcitabine triphosphate accumulation. J Clin Oncol 19:3483-3489, 2001 (Pubitemid 32730085)
9. Maki RG, Wathen JK, Patel SR, et al: Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: Results of sarcoma alliance for research through collaboration study 002 [corrected]. J Clin Oncol 25:2755-2763, 2007 (Pubitemid 47123184)
10. Buesa JM, Losa R, Fernández A, et al: Phase I clinical trial of fixed-dose rate infusional gemcitabine and dacarbazine in the treatment of advanced soft tissue sarcoma, with assessment of gemcitabine triphosphate accumulation. Cancer 101:2261-2269, 2004 (Pubitemid 39458682)
11. Losa R, Fra J, Ló pez-Pousa A, et al: Phase II study with the combination of gemcitabine and DTIC in patients with advanced soft tissue sarcomas. Cancer Chemother Pharmacol 59:251-259, 2007 (Pubitemid 44885154)
12. Van Glabbeke M, Verweij J, Judson I, et al: Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer 38:543-549, 2002 (Pubitemid 34185394)
13. Verweij J: Other endpoints in screening studies for soft tissue sarcomas. Oncologist 13:27-31, 2008 (suppl 2)
14. Schuetze SM, Baker LH, Benjamin RS, et al: Selection of response criteria for clinical trials of sarcoma treatment. Oncologist 13:32-40, 2008 (suppl 2)
15. Verweij J, Lee SM, Ruka W, et al: Randomized phase II study of docetaxel versus doxorubicin in first- and second-line chemotherapy for locally advanced or metastatic soft tissue sarcomas in adults: A study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol 18:2081-2086, 2000 (Pubitemid 30324361)
16. Köstler WJ, Brodowicz T, Attems Y, et al: Docetaxel as rescue medication in anthracycline-and ifosfamide-resistant locally advanced or metastatic soft tissue sarcoma: Results of a phase II trial. Ann Oncol 12:1281-1288, 2001 (Pubitemid 32994758)
17. Leu KM, Ostruszka LJ, Shewach D, et al: Laboratory and clinical evidence of synergistic cytotoxicity of sequential treatment with gemcitabine followed by docetaxel in the treatment of sarcoma. J Clin Oncol 22:1706-1712, 2004 (Pubitemid 41079810)