Phase II study of nedaplatin and irinotecan followed by gefitinib for elderly patients with unresectable non-small cell lung cancer

Cancer Chemotherapy and Pharmacology

Volumn 62, Issue 3, 2008, Pages 465-470

  Oshita, Fumihiro ^a   Yamada, Kouzo ^a   Saito, Haruhiro ^a   Noda, Kazumasa ^a  

^a KANAGAWA CANCER CENTER   (Japan)

Author keywords

Elderly; Gefitinib; Irinotecan; Lung cancer; Nedaplatin

Indexed keywords

DEXAMETHASONE; GEFITINIB; IRINOTECAN; NEDAPLATIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANEMIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BONE MARROW TOXICITY; BRAIN ISCHEMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFECT; DRY SKIN; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GASTRITIS; HUMAN; INFECTION; LUNG NON SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; NAIL; NAUSEA; NEUROPATHY; NEUTROPENIA; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; RASH; SIDE EFFECT; SKIN EXFOLIATION; SKIN TOXICITY; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR GROWTH; VOMITING;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; ORGANOPLATINUM COMPOUNDS; QUINAZOLINES;

EID: 45749107871     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-007-0626-1     Document Type: Article

References (21)

1. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. New Eng J Med 346:92-98
2. Langer CJ, Manola J, Bernardo P, Kugler JW, Bonomi P, Cella D, Johnson DH (2002) Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial. J Natl Cancer Inst 94:173-181
3. Oshita F, Kurata T, Kasai T, Fukuda M, Yamamoto N, Ohe Y, Tamura T, Eguchi K, Shinkai T, Saijo N (1995) Prospective evaluation of the feasibility of cisplatin-based chemotherapy for elderly lung cancer patients with normal organ functions. Jpn J Cancer Res 86:1198-1202
4. 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
5. Gridelli C, Perrone F, Gallo C, Cigolari S, Rossi A, Piantedosi F, Barbera S, Ferrau 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
6. Kanzawa F, Koizumi F, Koh Y, Nakamura T, Tatsumi Y, Fukumoto H, Saijo N, Yoshioka T, Nishio K (2001) In vitro synergistic interactions between the cisplatin analogue nadaplatin and the DNA topoisomerase I inhibitor irinotecan and the mechnism of this action. Clin Cancer Res 7:202-209
7. Oshita F, Yamada K, Kato Y, Ikehara M, Noda K, Tanaka G, Nomura I, Suzuki R, Saito H (2003) Phase I/II study of escalating doses of nedaplatin in combination with irinotecan for advanced non-small-cell lung cancer. Cancer Chemother Pharmacol 52:73-78
8. Oshita F, Yamada K, Saito H, Noda K, Hamanaka N, Ikehara M, Tanaka G (2004) Phase II study of nedaplatin and irinotecan for elderly patients with advanced non-small cell lung cancer. J Exp Ther Oncol 4:343-348
9. Fukuoka M, Yano S, Giaccone G, Tamura T, Nakagawa K, Douillard JY, Nishiwaki Y, Vansteenkiste J, Kudoh S, Rischin D, Eek R, Horai T, Noda K, Takata I, Smit E, Averbuch S, Macleod A, Feyereislova A, Dong RP, Baselga J (2003) Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial). J Clin Oncol 21:2237-2246
10. 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. J Natl Cancer Inst 92:205-216
11. National Cancer Institute-Common Toxicity Criteria ver.2. http://ctep.cancer.gov/reporting/CTC-3.html
12. Simon R (1989) Optimal two-stage designs for phase II clinical trial. Control Clin Trial 10:1-10
13. Lee YJ, Staquet M, Simon R, Catane R, Muggia F (1979) Two stage plans for patient accrual in phase II cancer clinical trials. Cancer Treat Rep 63:1721-1726
14. Cappuzzo F, Bartolini S, Ceresoli GL, Tamberi S, Spreafico A, Lombardo L, Gregorc V, Toschi L, Calandri C, Villa E, Crino L (2004) Efficacy and tolerability of gefitinib in pretreated elderly patients with advanced non-small-cell lung cancer (NSCLC). Br J Cancer 90:82-86
15. Kris MG, Natale RB, Herbst RS, Lynch TJ Jr, Prager D, Belani CP, Schiller JH, Kelly K, Spiridonidis H, Sandler A, Albain KS, Cella D, Wolf MK, Averbuch SD, Ochs JJ, Kay AC (2003) Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 290:2149-2158
16. Miller VA, Kris MG, Shah N, Patel J, Azzoli C, Gomez J, Krug LM, Pao W, Rizvi N, Pizzo B, Tyson L, Venkatraman E, Ben-Porat L, Memoli N, Zakowski M, Rusch V, Heelan RT (2004) Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer. J Clin Oncol 22:1103-1109
17. Thatcher N, Chang A, Parikh P, Rodrigues Pereira J, Ciuleanu T, von Pawel J, Thongprasert S, Tan EH, Pemberton K, Archer V, Carroll K (2005) Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 366:1527-1537
18. Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA (2004) Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350:2129-2139
19. Paez JG, Janne PA, Lee JC, Tracy S, Greulich H, Gabriel S, Herman P, Kaye FJ, Lindeman N, Boggon TJ, Naoki K, Sasaki H, Fujii Y, Eck MJ, Sellers WR, Johnson BE, Meyerson M (2004) EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304:1497-1500
20. Mitsudomi T, Kosaka T, Endoh H, Horio Y, Hida T, Mori S, Hatooka S, Shinoda M, Takahashi T, Yatabe Y (2005) Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small-cell lung cancer with postoperative recurrence. J Clin Oncol 23:2513-2520
21. Oshita F, Matsukuma S, Yoshihara M, Sakuma Y, Ohgane N, Kameda Y, Saito H, Yamada K, Tsuchiya E, Miyagi Y (2006) Novel heteroduplex method using small cytology specimens with a remarkably high success rate for analysing EGFR gene mutations with a significant correlation to gefitinib efficacy in non-small-cell lung cancer. Br J Cancer 95:1070-1075