A phase I/II trial of induction chemotherapy with carboplatin and gemcitabine followed by concurrent vinorelbine and paclitaxel with chest radiation in patients with stage III non-small cell lung cancer

Lung Cancer

Volumn 45, Issue 2, 2004, Pages 243-253

  Argiris, A ^a   Liptay, M ^a,b   LaCombe, M ^a,b   Marymont, M ^a   Kies, M S ^a,c   Sundaresan, S ^a   Masters, G ^a,b  

^a NORTHWESTERN UNIVERSITY   (United States)

^b EVANSTON NORTHWESTERN HEALTHCARE   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Carboplatin; Chemotherapy; Gemcitabine; Non small cell lung cancer; Paclitaxel; Radiotherapy; Surgery; Vinorelbine

Indexed keywords

ANTIEMETIC AGENT; CARBOPLATIN; DEXAMETHASONE; GEMCITABINE; HISTAMINE H1 RECEPTOR ANTAGONIST; HISTAMINE H2 RECEPTOR ANTAGONIST; NAVELBINE; PACLITAXEL;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURGERY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; CYTOTOXICITY; DERMATITIS; DOSE RESPONSE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG TOLERABILITY; ELECTROCORTICOGRAPHY; ESOPHAGITIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; INFECTION; LUNG FUNCTION; LUNG NON SMALL CELL CANCER; LYMPH NODE METASTASIS; MALE; MEDIASTINUM LYMPH NODE; MUCOSA INFLAMMATION; MULTIMODALITY CANCER THERAPY; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PREMEDICATION; PRIORITY JOURNAL; SIDE EFFECT; STOMATITIS; SURVIVAL RATE; SURVIVAL TIME; THORACOTOMY; THROMBOCYTE; THROMBOCYTOPENIA; TOXICITY;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; PROBABILITY; PROGNOSIS; RADIOTHERAPY DOSAGE; RADIOTHERAPY, ADJUVANT; REMISSION INDUCTION; STATISTICS, NONPARAMETRIC; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VINBLASTINE;

EID: 3042715921     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2004.02.008     Document Type: Article

References (49)

1. Jemal A., Murray T., Samuels A., Ghafoor A., Ward E., Thun M.J. Cancer statistics. CA Cancer J. Clin. 53:2003;5-26
2. Mountain C.F. Revisions in the international system for staging lung cancer. Chest. 111:1997;1710-1717
3. Martini N., Flehinger B.J., Zaman M.B., Beattie E.J. Jr. Results of resection in non-oat cell carcinoma of the lung with mediastinal lymph node metastases. Ann. Surg. 198:1983;386-397
4. Albain K.S., Rusch V.W., Crowley J.J., Rice T.W., Turrisi A.T. III, Weick J.K., et al. Concurrent cisplatin/etoposide plus chest radiotherapy followed by surgery for stages IIIA (N2) and IIIB non-small-cell lung cancer: mature results of Southwest Oncology Group phase II study 8805. J. Clin. Oncol. 13:1995;1880-1892
5. Albain K.S., Crowley J.J., Turrisi A.T. III, Gandara D.R., Farrar W.B., Clark J.I., et al. Concurrent cisplatin, etoposide, and chest radiotherapy in pathologic stage IIIB non-small-cell lung cancer: a Southwest Oncology Group phase II study, SWOG 9019. J. Clin. Oncol. 20:2002;3454-3460
6. Roth J.A., Fossella F., Komaki R., Ryan M.B., Putnam J.B. Jr., Lee J.S., et al. A randomized trial comparing perioperative chemotherapy and surgery with surgery alone in resectable stage IIIA non-small-cell lung cancer. J. Natl. Cancer Inst. 86:1994;673-680
7. Rosell R., Gomez-Codina J., Camps C., Maestre J., Padille J., Canto A., et al. A randomized trial comparing preoperative chemotherapy plus surgery with surgery alone in patients with non-small-cell lung cancer. N. Engl. J. Med. 330:1994;153-158
8. Depierre A., Milleron B., Moro-Sibilot D., Chevret S., Quoix E., Lebeau B., et al. Preoperative chemotherapy followed by surgery compared with primary surgery in resectable stage I (except T1N0), II, and IIIa non-small-cell lung cancer. J. Clin. Oncol. 20:2002;247-253
9. Eberhardt W., Wilke H., Stamatis G., Stuschke M., Harstrick A., Menker H., et al. Preoperative chemotherapy followed by concurrent chemoradiation therapy based on hyperfractionated accelerated radiotherapy and definitive surgery in locally advanced non-small-cell lung cancer: mature results of a phase II trial. J. Clin. Oncol. 16:1998;622-634
10. Choi N.C., Carey R.W., Daly W., Mathisen D., Wain J., Wright C., et al. Potential impact on survival of improved tumor downstaging and resection rate by preoperative twice-daily radiation and concurrent chemotherapy in stage IIIA non-small-cell lung cancer. J. Clin. Oncol. 15:1997;712-722
11. Strauss G.M., Herndon J.E., Sherman D.D., Mathisen D.J., Carey R.W., Choi N.C., et al. Neoadjuvant chemotherapy and radiotherapy followed by surgery in stage IIIA non-small-cell carcinoma of the lung: report of a Cancer and Leukemia Group B phase II study. J. Clin. Oncol. 10:1992;1237-1244
12. Albain K.S., Scott C.B., Rusch V.R., Turrisi A.T., Shepherd F.A., Smith C., et al. Phase III comparison of concurrent chemotherapy plus radiotherapy (CT/RT) and CT/RT followed by surgical resection for stage IIIA(pN2) non-small cell lung cancer (NSCLC): initial results from intergroup trial 0139 (RTOG 93-09). Proc. Am. Soc. Clin. Oncol. 22:2003;A2497
13. Le Chevalier T., Arriagada R., Quoix E., Ruffie P, Martin M., Douillard J.Y., et al. Radiotherapy alone versus combined chemotherapy and radiotherapy in unresectable non-small cell lung carcinoma. Lung Cancer. 10(Suppl. 1):1994;S239-S244
14. Dillman R.O., Seagren S.L., Propert K.J., Guerra J., Eaton W.L., Perry M.C., et al. A randomized trial of induction chemotherapy plus high-dose radiation versus radiation alone in stage III non-small-cell lung cancer. N. Engl. J. Med. 323:1990;940-945
15. Sause W.T., Scott C., Taylor S., Johnson D., Livingston R., Komaki R., et al. Radiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer. J. Natl. Cancer Inst. 87:1995;198-205
16. Furuse K., Fukuoka M., Kawahara M., Nishikawa H., Takada Y., Kudoh S., et al. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J. Clin. Oncol. 17:1999;2692-2699
17. Curran J.W.J., Scott C., Langer C., Komaki R., Lee J.S., Hauser S., et al. Phase III comparison of sequential vs. concurrent chemoradiation for patients (pts) with unresected stage III non-small cell lung cancer (NSCLC): initial report of Radiation Therapy Oncology Group (RTOG). Proc. Am. Soc. Clin. Oncol. 19:2000;A1891
18. Choy H., Curran W.J. Jr., Scott C.B., Bonomi P., Travis P., Haluschak J., et al. Preliminary report of locally advanced multimodality protocol (LAMP) ACR 427: a randomized phase II study of three chemo-radiation regimens with paclitaxel, carboplatin, and thoracic radiation (TRT) for patients with locally advanced non small cell lung cancer (LA-NSCLC). Proc. Am. Soc. Clin. Oncol. 21:2002;A1160
19. Zemanova M., Petruzelka L., Zemanova M., Havel L., Pecen L., Krepela E., et al. Concurrent versus sequential radiochemotherapy with vinorelbine plus cisplatin (V-P) in locally advanced non-small cell lung cancer. A randomized phase II study. Proc. Am. Soc. Clin. Oncol. 21:2002;A1159
20. Vokes E.E., Herndon J.E. II, Crawford J., Crawford J., Leopold K.A., Perry M.C., Miller A.A., et al. Randomized phase II study of cisplatin with gemcitabine or paclitaxel or vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy for stage IIIB non-small-cell lung cancer: Cancer and Leukemia Group B study 9431. J. Clin. Oncol. 20:2002;4191-4198
21. Gandara D.R., Chansky K., Albain K.S., Leigh B.R., Gaspar L.E., Lara P.N. Jr., et al. Consolidation docetaxel after concurrent chemoradiotherapy in stage IIIB non-small-cell lung cancer: phase II Southwest Oncology Group study S9504. J. Clin. Oncol. 21:2003;2004-2010
22. Vokes E.E., Weichselbaum R.R. Concomitant chemoradiotherapy: rationale and clinical experience in patients with solid tumors. J. Clin. Oncol. 8:1990;911-934
23. Jassem J. Combined chemotherapy and radiation in locally advanced non-small-cell lung cancer. Lancet Oncol. 2:2001;335-342
24. Crawford J., O'Rourke M., Schiller J.H., Spiridonidis C.H., Yanovich S., Ozer H., et al. Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non-small-cell lung cancer. J. Clin. Oncol. 14:1996;2774-2784
25. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer. The Elderly Lung Cancer Vinorelbine Italian Study Group. J Natl Cancer Inst 1999;91:66-72.
26. Edelstein M.P., Wolfe L.A. III, Duch D.S. Potentiation of radiation therapy by vinorelbine (navelbine) in non-small cell lung cancer. Semin. Oncol. 23:1996;41-47
27. Fukuoka K., Arioka H., Iwamoto Y., Fukumoto H., Uetani K., Suruda T., et al. Mechanism of the radiosensitization induced by vinorelbine in human non-small cell lung cancer cells. Lung Cancer. 34:2001;451-460
28. Masters G.A., Haraf D.J., Hoffman P.C., Drinkard L.C., Krauss S.A., Ferguson M.K., et al. Phase I study of vinorelbine, cisplatin, and concomitant thoracic radiation in the treatment of advanced chest malignancies. J. Clin. Oncol. 16:1998;2157-2163
29. Hoffman P.C., Cohen E.E., Masters G.A., Haraf D.J., Mauer A.M., Rudin C.M., et al. Carboplatin plus vinorelbine with concomitant radiation therapy in advanced non-small cell lung cancer: a phase I study. Lung Cancer. 38:2002;65-71
30. Ramalingam S., Belani C.P. Taxanes for advanced non-small cell lung cancer. Expert Opin. Pharmacother. 3:2002;1693-1709
31. Murphy W.K., Fossella F.V., Winn R.J., Shin D.M., Hynes H.E., Gross H.M., et al. Phase II study of taxol in patients with untreated advanced non-small-cell lung cancer. J. Natl. Cancer Inst. 85:1993;384-388
32. Chang A.Y., DeVore R., Johnson D. Pilot study of vinorelbine (navelbine) and paclitaxel in patients with refractory non-small cell lung cancer. Semin. Oncol. 23:1996;19-21
33. Choy H., Akerley W., Safran H., Clark J., Rege V., Papa A., et al. Phase I trial of outpatient weekly paclitaxel and concurrent radiation therapy for advanced non-small-cell lung cancer. J. Clin. Oncol. 12:1994;2682-2686
34. Choy H., Akerley W., Safran H., Graziano S., Chung C., Williams T., et al. Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J. Clin. Oncol. 16:1998;3316-3322
35. Migliorino M.R., De Marinis F., Nelli F., Facciolo F., Ammaturo M.V., Cipri A., et al. A 3-week schedule of gemcitabine plus cisplatin as induction chemotherapy for stage III non-small cell lung cancer. Lung Cancer. 35:2002;319-327
36. Voltolini L., Luzzi L., Ghiribelli C., Paladini P., Di Bisceglie M., Gotti G. Results of induction chemotherapy followed by surgical resection in patients with stage IIIA (N2) non-small cell lung cancer: the importance of the nodal down-staging after chemotherapy. Eur. J. Cardiothorac. Surg. 20:2001;1106-1112
37. Depierre A., Westeel V., Jacoulet P. Gemcitabine induction chemotherapy in non-small cell lung cancer. Semin. Oncol. 29:2002;55-60
38. Edelman M.J. Past, present, and future of gemcitabine and carboplatin regimens in advanced non-small cell lung cancer. Lung Cancer. 38(Suppl. 2):2002;S37-S43
39. Argiris A., Masters G. Carboplatin and gemcitabine for advanced non-small cell lung cancer: an emerging standard doublet. Cancer Conference Highlights. 7:2003;5-8
40. Calvert A.H., Newell D.R., Grumbell L.A., et al. Carboplatin dosage. Prospective evaluation of a single formula based on renal function. J. Clin. Oncol. 7:1989;1748-1756
41. Kaplan E., Meier P. Nonparametric estimation from incomplete observations. J. Am. Stat. Assoc. 53:1958;457-481
42. Rinaldi M., Crino L. Induction chemotherapy with gemcitabine and cisplatin in stage III non-small cell lung cancer. Lung Cancer. 34(Suppl. 4):2001;S25-S30
43. Zatloukal P, Novakova L, Petruzelka L, Zemanova M, Kolek V, Grygarkova I, et al. Gemcitabine plus cisplatin (GCis) versus gemcitabine plus carboplatin (GCarb) in patients with stage IIIB and IV non-small cell lung cancer (NSCLC): final results of Czech Lung Cancer Cooperative Group phase III randomized trial. Proc Am Soc Clin Oncol 2002;21.
44. Mazzanti P., Massacesi C., Mattioli R., Trivisonne R., Buzzi F., De Signoribus G., et al. Gemcitabine-cisplatin vs. gemcitabine-carboplatin in advanced non-small cell lung cancer: a multicenter phase II randomized trial. Eur. J. Cancer. 37:2001;a172
45. Sederholm C. Gemcitabine (G) compared with gemcitabine plus carboplatin (GC) in advanced non-small cell lung cancer (NSCLC): a phase III study by the Swedish Lung Cancer Study Group (SLUSG). Proc Am Soc Clin Oncol 2002;21.
46. Rudd R.M., Gower N.H., James L.E., Gregory W., Eisen T., Lee S.M., et al. Phase III randomised comparison of gemcitabine and carboplatin (GC) with mitomycin, with mitomycin, ifosfamide and cisplatin (MIP) in advanced non-small cell lung cancer. Proc. Am. Soc. Clin. Oncol. 21:2002;A1164
47. Grigorescu A.C., Draghici I.N., Nitipir C., Gutulescu N., Corlan E. Gemcitabine (GEM) and carboplatin (CBDCA) versus cisplatin (CDDP) and vinblastine (VLB) in advanced non-small-cell lung cancer (NSCLC) stages III and IV: a phase III randomised trial. Lung Cancer. 37:2002;9-14
48. Sauvaget J., Rebischung J.-L., Vannetzel J.-M. Phase III study of neo-adjuvant MVP versus MVP plus chemo-radiotherapy in stage III NSCLC. Proc. Am. Soc. Clin. Oncol. 19:2000;A1935
49. Macbeth F. Radiation myelitis and thoracic radiotherapy: evidence and anecdote. Clin. Oncol. (R. Coll. Radiol.). 12:2000;333-334