A phase II trial of prolonged, continuous infusion of low-dose gemcitabine plus cisplatin in patients with advanced malignant pleural mesothelioma

Cancer Chemotherapy and Pharmacology

Volumn 73, Issue 5, 2014, Pages 975-982

  Arrieta, Oscar ^a   López Macías, Diego ^a   Mendoza García, Víctor Osvaldo ^a   Bacon Fonseca, Ludwing ^a   Muñoz Montaño, Wendy ^a   Macedo Pérez, Eleazar Omar ^a   Muñiz Hernández, Saé ^a   Blake Cerda, Monika ^a   Corona Cruz, José Francisco ^a  

^a INSTITUTO NACIONAL DE CANCEROLOGÍA   (Mexico)

Author keywords

Cisplatin; Gemcitabine; Mesothelioma; Prolonged infusion

Indexed keywords

ALANINE AMINOTRANSFERASE; APREPITANT; ASPARTATE AMINOTRANSFERASE; CARBOPLATIN; CISPLATIN; CREATININE; DEXAMETHASONE; GEMCITABINE; ONDANSETRON;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER PATIENT; CANCER STAGING; CONTINUOUS INFUSION; CREATININE BLOOD LEVEL; DIARRHEA; DISEASE CONTROL; DISEASE COURSE; DRUG EFFICACY; DRUG WITHDRAWAL; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HEALTH STATUS; HUMAN; LABORATORY TEST; LEUKOPENIA; LOW DRUG DOSE; LOWEST INCOME GROUP; LYMPHOCYTOPENIA; MALE; MEDICAL HISTORY; MUCOSA INFLAMMATION; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PHYSICAL EXAMINATION; PLEURA MESOTHELIOMA; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; SOFT TISSUE INFECTION; THROMBOCYTOPENIA; TOXICITY; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; CISPLATIN; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MESOTHELIOMA; MIDDLE AGED; PROGNOSIS; QUALITY OF LIFE; SURVIVAL ANALYSIS;

EID: 84900806751     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2429-5     Document Type: Article

References (45)

1. Selikoff IJ, Hammond EC, Seidman H (1980) Latency of asbestos disease among insulation workers in the United States and Canada. Cancer 46(12):2736-2740 (Pubitemid 11210245)
2. Tsao AS, Wistuba I, Roth JA et al (2009) Malig Pleur Mesothelioma J Clin Oncol 27(12):2081-2090. doi:10.1200/JCO.2008.19.8523
3. Delgermaa V, Takahashi K, Park EK et al (2011) Global mesothelioma deaths reported to the World Health Organization between 1994 and 2008. Bull World Health Organ 89(10):716-724. doi:10.2471/BLT.11.086678 724A-724C
4. Aguilar-Madrid G, Robles-Pérez E, Juárez-Pérez CA et al (2010) Case-control study of pleural mesothelioma in workers with social security in Mexico. Am J Ind Med 53(3):241-251
5. García-López MP, Barrera-Rodríguez R (2000) Malignant mesothelioma: clinical and radiological description of 45 cases with and without asbestos exposure. Salud Publica Mex 42(6):511-519
6. Park EK, Takahashi K, Hoshuyama T et al (2011) Global magnitude of reported and unreported mesothelioma. Environ Health Perspect 119(4):514-518. doi:10.1289/ehp.1002845
7. NCCN Guidelines for Treatment of Malignat Pleural Mesothelioma (2013) IOP National Comprehensive Cancer Network Web. http://www.nccn.org/professionals/ physician-gls/f-guidelines.asp#site. Accessed 23 Dec 2013
8. Vogelzang NJ, Rusthoven JJ, Symanowski J et al (2003) Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 21(14):2636-2644 (Pubitemid 46606305)
9. van Meerbeeck JP, Gaafaar R, Manegold C et al (2005) Randomized phase III Study of Cisplatin With or Without Ralitrexed in Patients with Malignant Pleural Mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol 23(28):2636-2644
10. Kelly RJ, Sharon E, Hassan R (2011) Chemotherapy and targeted therapies for unresectable malignant mesothelioma. Lung Cancer 73(3):256-263. doi:10.1016/j.lungcan.2011.04.014
11. Nowak AK, Byrne MJ, Williamson R et al (2002) A multicenter phase II study of cisplatin and gemcitabine for malignant mesothelioma. Br J Cancer 87(5):491-496
12. Arrieta Ó, Medina LA, Estrada-Lobato E et al (2012) First-line chemotherapy with liposomal doxorubicin plus cisplatin for patients with advanced malignant pleural mesothelioma: phase II trial. Br J Cancer 106(6):1027-1032. doi:10.1038/bjc.2012.44
13. Ralli M, Tourkantonis I, Makrilia N et al (2009) Docetaxel plus gemcitabine as first-line treatment in malignant pleural mesothelioma: a single institution phase II study. Anticancer Res 29(8):3441-3444
14. Sørensen JB, Frank H, Palshof T (2008) Cisplatin and vinorelbine first-line chemotherapy in non-resectable malignant pleuralmesothelioma. Br J Cancer 99(1):44-50. doi:10.1038/sj.bjc.6604421 (Pubitemid 351920221)
15. Boons CC, VAN Tulder MW, Burgers JA et al (2013) The value of pemetrexed for the treatment of malignant pleural mesothelioma: a comprehensive review. Anticancer 33(9):3553-3561
16. Grossi F, Genova C, Gaitan ND et al (2013) Free drugs in clinical trials and their potential cost saving impact on the National Health Service: a retrospective cost analysis in Italy. Lung Cancer 81(2):236-240. doi:10.1016/j.lungcan.2013.03.021
17. Woods B, Paracha N, Scott DA et al (2012) Raltitrexed plus cisplatin is cost-effective compared with pemetrexed plus cisplatin in patients with malignant pleural mesothelioma. Lung Cancer 75(2):261-267. doi:10.1016/j. lungcan.2011.07.011
18. Zwitter M, Kovac V, Smrdel U et al (2009) Gemcitabine in brief versus prolonged low-dose infusion, both combined with cisplatin, for advanced non-small cell lung cancer: a randomized phase II clinical trial. J Thorac Oncol 4(9):1148-1155. doi:10.1097/JTO.0b013e3181ae280f
19. Sezer O, Eucker J, Jakob C et al (2001) Achievement of complete remission in refractory Hodgkin's disease with prolonged infusion of gemcitabine. Invest New Drugs 19(1):101-104 (Pubitemid 32209792)
20. Brand R, Capadano M, Tempero M (2007) A phase I trial of weekly gemcitabine administered as a prolonged infusion in patients with pancreatic cancer and other solid tumors. Invest New Drugs 15(4):331-341
21. Akrivakis K, Schmid P, Flath B et al (1999) Prolonged infusion of gemcitabine in stage IV breast cancer: a phase I study. Anticancer Drugs 10(6):525-531 (Pubitemid 29410798)
22. Cattel L, Airoldi M, Delprino L et al (2006) Pharmacokinetic evaluation of gemcitabine and 2′,2′-difluorodeoxycytidine-5′-triphosphate after prolonged infusion in patients affected by different solid tumors. Ann Oncol 17(Suppl 5):v142-v147 (Pubitemid 43985224)
23. Maurel J, Zorrilla M, Puertolas T et al (2001) Phase I trial of weekly gemcitabine at 3-h infusion in refractory, heavily pretreated advanced solid tumors. Anticancer Drugs 12(9):713-717 (Pubitemid 33001183)
24. Anderson H, Thatcher N, Walling J et al (1996) A phase I study of a 24 hour infusion of gemcitabine in previously untreated patients with inoperable non-small-cell lung cancer. Br J Cancer 74(3):460-462 (Pubitemid 26254579)
25. 2) levels. Invest New Drugs 15(2):115-121
26. Touroutoglou N, Gravel D, Raber MN et al (1998) Clinical results of a pharmacodynamically based strategy for higher dosing of gemcitabine in patients with solid tumors. Ann Oncol 9(9):1003-1008 (Pubitemid 28496710)
27. Abbruzzese JL, Grunewald R, Weeks EA et al (1991) A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol 9(3):491-498
28. Plunkett W, Huang P, Xu YZ et al (1995) Gemcitabine: metabolism, mechanisms of action, and self-potentiation. Semin Oncol 22(4 Suppl 11):3-10
29. Edwards JG, Abrams KR, Leverment JN et al (2000) Prognostic factors for malignant mesothelioma in 142 patients: validation of CALGB and EORTC prognostic scoring systems. Thorax 55(9):731-735 (Pubitemid 30660898)
30. Fennell DA, Parmar A, Shamash J et al (2005) Statistical validation of the EORTC prognostic model for malignant pleural mesothelioma based on three consecutive phase II trials. J Clin Oncol 23(1):184-189 (Pubitemid 41702637)
31. Arrieta Ó, Núñez-Valencia C, Reynoso-Erazo L et al (2012) Health-related quality of life in patients with lung cancer: validation of the Mexican-Spanish version and association with prognosis of the EORTC QLQ-LC13 questionnaire. Lung Cancer 77(1):205-211. doi:10.1016/j.lungcan.2012. 02.005
32. Schouwink JH, Kool LS, Rutgers EJ et al (2003) The value of chest computer tomography and cervical mediastinoscopy in the preoperative assessment of patients with malignant pleural mesothelioma. Ann Thorac Surg 75(6):1715-1718 (Pubitemid 36677200)
33. Byrne MJ, Davidson JA, Musk AW, Dewar J, van Hazel G, Buck M, de Klerk NH, Robinson BW et al (1999) Cisplatin and gemcitabine treatment for malignant mesothelioma: a phase II study. J Clin Oncol 17(1):25-30 (Pubitemid 29022374)
34. van Haarst JM, Baas P, Manegold Ch et al (2002) Multicentre phase II study of gemcitabine and cisplatin in malignant pleural mesothelioma. Br J Cancer 86(3):342-345 (Pubitemid 34187648)
35. Kalmadi SR, Rankin C, Kraut MJ et al (2008) Gemcitabine and cisplatin in unresectable malignant mesothelioma of the pleura: a phase II study of the Southwest Oncology Group (SWOG 9810). Lung Cancer 60(2):259-263 (Pubitemid 351609140)
36. Castagneto B, Zai S, Dongiovanni D et al (2005) Cisplatin and gemcitabine in malignant pleural mesothelioma: a phase II study. Am J Clin Oncol 28(3):223-226 (Pubitemid 40800471)
37. Favaretto AG, Aversa SM, Paccagnella A et al (2003) Gemcitabine combined with carboplatin in patients with malignant pleural mesothelioma: a multicentric phase II study. Cancer 97(11):2791-2797 (Pubitemid 36605147)
38. Ceribelli A, Gridelli C, De Marinis F et al (2003) Prolonged gemcitabine infusion in advanced non-small cell lung cancer carcinoma: a randomized phase II study of two different schedules in combination with cisplatin. Cancer 98(2):337-343 (Pubitemid 36828459)
39. de Perrot M, Feld R, Cho BC et al (2009) Trimodality therapy with induction chemotherapy followed by extrapleural pneumonectomy and adjuvant high-dose hemithoracic radiation for malignant pleural mesothelioma. J Clin Oncol 27(9):1413-1418. doi:10.1200/JCO.2008.17.5604
40. Lee CW, Murray N, Anderson H et al (2009) Outcomes with first-line platinum-based combination chemotherapy for malignant pleural mesothelioma: a review of practice in British Columbia. Lung Cancer 64(3):308-313. doi:10.1016/j.lungcan.2008.09.008
41. Kovac V, Zwitter M, Rajer M et al (2012) A phase II trial of low-dose gemcitabine in a prolonged infusion and cisplatin for malignant pleural mesothelioma. Anticancer Drugs 23(2):230-238. doi:10.1097/CAD.0b013e32834d7a1c
42. Rea F, Marulli G, Bortolotti L et al (2007) Induction chemotherapy, extrapleural pneumonectomy (EPP) and adjuvant hemithoracic radiation in malignant pleural mesothelioma (MPM): feasibility and results. Lung Cancer 57(1):89-95 (Pubitemid 46843340)
43. Bottomley A, Coens C, Efficace F et al (2007) Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol 25(36):5770-5776
44. Flores RM, Pass HI, Seshan VE et al (2008) Extrapleural pneumonectomy versus pleurectomy/decortication in the surgical management of malignant pleural mesothelioma: results in 663 patients. J Thorac Cardiovasc Surg 135(3):620-626. doi:10.1016/j.jtcvs.2007.10.054
45. Treasure T, Lang-Lazdunski L, Waller D et al (2011) Extra-pleural pneumonectomy versus no extra-pleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol 12(8):763-772. doi:10.1016/S1470-2045(11)70149-8