Phase II study of pemetrexed as first-line treatment in elderly (≥75) non-squamous non-small-cell lung cancer: Kyoto Thoracic Oncology Research Group Trial 0901

Cancer Chemotherapy and Pharmacology

Volumn 71, Issue 6, 2013, Pages 1445-1451

  Kim, Young Hak ^a   Hirabayashi, Masataka ^b   Kosaka, Shinji ^c   Nikaidoh, Junichi ^b   Yamamoto, Yasumichi ^c   Shimada, Masatoshi ^b   Toyazaki, Toshiya ^c   Nagai, Hiroki ^a   Sakamori, Yuichi ^a   Mishima, Michiaki ^a  

^a KYOTO UNIVERSITY   (Japan)

^b HYOGO PREFECTURAL AMAGASAKI GENERAL MEDICAL CENTER   (Japan)

^c SHIMANE PREFECTURAL CENTRAL HOSPITAL   (Japan)

Author keywords

Elderly; Non small cell lung cancer; Non squamous; Pemetrexed; Phase II study

Indexed keywords

CYANOCOBALAMIN; DOCETAXEL; ERLOTINIB; GEFITINIB; PEMETREXED; PROTEIN TYROSINE KINASE INHIBITOR;

ADENOCARCINOMA; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HISTOLOGY; HUMAN; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MALE; MEDICAL RESEARCH; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; ONCOLOGY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUTAMATES; GUANINE; HUMANS; JAPAN; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; PROSPECTIVE STUDIES;

EID: 84878633949     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-013-2142-9     Document Type: Article

References (24)

1. Gridelli C, Aapro M, Ardizzoni A, Balducci L, De Marinis F, Kelly K, Le Chevalier T, Manegold C, Perrone F, Rosell R, Shepherd F, De Petris L, Di Maio M, Langer C (2005) Treatment of advanced non-small-cell lung cancer in the elderly: results of an international expert panel. J Clin Oncol 23:3125-3137
2. Hutchins LF, Unger JM, Crowley JJ, Coltman CA Jr, Albain KS (1999) Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341:2061-2067
3. The Elderly Lung Cancer Vinorelbine Italian Study Group (1999) Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 91:66-72
4. Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferraù F, Piazza E, Rosetti F, Clerici M, Bertetto O, Robbiati SF, Frontini L, Sacco C, Castiglione F, Favaretto A, Novello S, Migliorino MR, Gasparini G, Galetta D, Iaffaioli RV, Gebbia V, MILES Investigators (2003) Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial. J Natl Cancer Inst 95:362-372
5. Kudoh S, Takeda K, Nakagawa K, Takada M, Katakami N, Matsui K, Shinkai T, Sawa T, Goto I, Semba H, Seto T, Ando M, Satoh T, Yoshimura N, Negoro S, Fukuoka M (2006) Phase III study of docetaxel compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer: results of the West Japan Thoracic Oncology Group Trial (WJTOG 9904). J Clin Oncol 24:3657-3663
6. D'Addario G, Fruh M, Reck M, Baumann P, Klepetko W, Felip E, ESMO Guidelines Working Group (2010) Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 21(Suppl 5):v116-v119
7. de Marinis F, Rossi A, Di Maio M, Ricciardi S, Gridelli C (2011) Treatment of advanced non-small-cell lung cancer: Italian Association of Thoracic Oncology (AIOT) clinical practice guidelines. Lung Cancer 73:1-10
8. Muhsin M, Gricks C, Kirkpatrick P (2004) Pemetrexed disodium. Nat Rev Drug Discov 3:825-826
9. Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA Jr (2004) Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 22:1589-1597
10. Weiss GJ, Langer C, Rosell R, Hanna N, Shepherd F, Einhorn LH, Nguyen B, Paul S, McAndrews P, Bunn PA Jr, Kelly K (2006) Elderly patients benefit from second-line cytotoxic chemotherapy: a subset analysis of a randomized phase III trial of pemetrexed compared with docetaxel in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 24:4405-4511
11. Scagliotti G, Hanna N, Fossella F, Sugarman K, Blatter J, Peterson P, Simms L, Shepherd FA (2009) The differential efficacy of pemetrexed according to NSCLC histology: a review of two Phase III studies. Oncologist 14:253-263
12. Scagliotti G, Brodowicz T, Shepherd FA, Zielinski C, Vansteenkiste J, Manegold C, Simms L, Fossella F, Sugarman K, Belani CP (2011) Treatment-by-histology interaction analyses in three phase III trials show superiority of pemetrexed in nonsquamous non-small cell lung cancer. J Thorac Oncol 6:64-70
13. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
14. Azzoli CG, Temin S, Aliff T, Baker S Jr, Brahmer J, Johnson DH, Laskin JL, Masters G, Milton D, Nordquist L, Pao W, Pfister DG, Piantadosi S, Schiller JH, Smith R, Smith TJ, Strawn JR, Trent D, Giaccone G, American Society of Clinical Oncology (2011) 2011 focused update of 2009 American Society of Clinical Oncology clinical practice guideline update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 29:3825-3831
15. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH, Eastern Cooperative Oncology Group (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98
16. Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, Negoro S, Nishiwaki Y, Saijo N, Ariyoshi Y, Fukuoka M (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol 18:317-323
17. Pallis AG, Gridelli C, van Meerbeeck JP, Greillier L, Wedding U, Lacombe D, Welch J, Belani CP, Aapro M (2010) EORTC Elderly Task Force and Lung Cancer Group and International Society for Geriatric Oncology (SIOG) experts' opinion for the treatment of non-small-cell lung cancer in an elderly population. Ann Oncol 21:692-706
18. Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducoloné A, Lebitasy MP, Baudrin L, Laporte S, Milleron B, Intergroupe Francophone de Cancérologie Thoracique (2011) Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet 378:1079-1088
19. Abe T, Yokoyama A, Takeda K, Ohe Y, Kudoh S, Ichinose Y, Okamoto H, Yamamoto N, Yoshioka H, Minato K, Sawa T, Iwamoto Y, Saka H, Mizusawa J, Shibata T, Nakamura S, Ando M, Nakagawa K, Saijo N, Tamura T (2011) Randomized phase III trial comparing weekly docetaxel (D)-cisplatin (P) combination with triweekly D alone in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC): an intergroup trial of JCOG0803/WJOG4307L. J Clin Oncol 29:7509 (ASCO Meeting Abstracts)
20. Guetz G, Uzzan B, Nicolas P, Valeyre D, Sebbane G, Morere JF (2012) Comparison of the efficacy and safety of single-agent and doublet hemotherapy in advanced non-small cell lung cancer in the elderly: a meta-analysis. Crit Rev Oncol Hematol 84(3):340-349
21. Lilenbaum R, Zukin M, Pereira JR, Barrios CH, De Albuquerque Ribeiro R, Beato CAdM, Neron do Nascimento Y, Murad A, Franke FA, Precivale M, de Lima Araujo LH, Baldotto CSDR, Vieira FM, Small IA, Ferreira CGM (2012) A randomized phase III trial of single-agent pemetrexed (P) versus carboplatin and pemetrexed (CP) in patients with advanced non-small cell lung cancer (NSCLC) and performance status (PS) of 2. J Clin Oncol 30:7506 (ASCO Meeting Abstracts)
22. Dy GK, Molina JR, Qi Y, Ansari RH, Thomas SP, Ross HJ, Meyers JP, Adjei A, Mandrekar SJ, Adjei AA, North Central Cancer Treatment Group (2012) N0821: a phase II first-line study of a combination of pemetrexed (P), carboplatin (C), and bevacizumab (B) in elderly patients with good performance status (PS < 2). J Clin Oncol 30:7555 (ASCO Meeting Abstracts)
23. Kim YH, Yoh K, Niho S, Goto K, Ohmatsu H, Kubota K, Nishiwaki Y (2010) Trends in chemotherapy for elderly patients with advanced non-small-cell lung cancer. Respir Med 104:434-439
24. Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C (2012) Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol 13:247-255