Phase Ia/Ib chemo-radiation trial of gemcitabine and dose-escalated thoracic radiation in patients with stage III A/B non-small cell lung cancer

Journal of Thoracic Oncology

Volumn 1, Issue 5, 2006, Pages 434-440

  Blackstock, A William ^a   Ho, Coty ^a   Butler, Jerome ^a   Fletcher Steede, June ^a   Case, L Douglas ^a   Hinson, William ^a   Miller, Antonius A ^a  

^a WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

Dose escalation; Gemcitabine; Locally advanced; Lung cancer; Radiation

Indexed keywords

CARBOPLATIN; GEMCITABINE; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; DRUG DOSE ESCALATION; DYSPNEA; ESOPHAGITIS; FEMALE; HUMAN; LUNG NON SMALL CELL CANCER; LUNG TOXICITY; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING; ESOPHAGUS; FORCED EXPIRATORY VOLUME; LUNG; LUNG TUMOR; MIDDLE AGED; MORTALITY; MULTIMODALITY CANCER THERAPY; PATHOLOGY; RADIATION DOSE; RADIATION EXPOSURE; RADIOTHERAPY; THORAX;

AGED; AGED, 80 AND OVER; ANTIMETABOLITES, ANTINEOPLASTIC; CARCINOMA, NON-SMALL-CELL LUNG; COMBINED MODALITY THERAPY; DEOXYCYTIDINE; ESOPHAGUS; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; LUNG; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; RADIOTHERAPY; RADIOTHERAPY DOSAGE; THORAX;

EID: 34247247789     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/01243894-200606000-00010     Document Type: Article

References (49)

1. Jemal A, Tiwari RC, Murray T, et al. Cancer statistics, 2004. CA Cancer J Clin 2004;54:8-29.
2. Reis L, Kosary C, Hankey B. SEER cancer statistics review, 1973-1996. Bethesda, MD: SEER,1999.
3. Curran W, Scott C, Langer C, et al. Phase III comparison of sequential versus concurrent chemoradiation for patients with unresectable stage III non small cell lung cancer (NSCLC): initial report of the radiation therapy oncology group (RTOG) 9410. Proceedings of ASCO 2000;19:484.
4. Furuse K, Fukuoka M, Kawahara M, 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 1999;17:2692-2699.
5. Varveris C, Lyraraki E, Kachris S, et al. Phase I/II study of gemcitabine combined with cisplatin weekly and concurrent thoracic MV-radiotherapy for patients with stage IIIA/B non small cell lung cancer (NSCLC) (Abstract). Proc Am Soc Clin Oncol 2000;19:A2116.
6. Divers SG, Busby E, Spencer S, et al. Sequential and concomitant chemoradiotherapy with gemcitabine-based chemotherapy for inoperable stage III non-small cell lung cancer (NSCLC): a phase I/IIa study (Abstract). Proc Am Soc Clin Oncol 2003;22:A2641.
7. Athanasiou E, Cyrgias G, Boinis K. Concurrent chemoradiotherapy with gemcitabine for locally advanced non-small cell lung cancer (NSCLC): Preliminary results of a phase II study (Abstract). Ann Oncol 1998;9 (Suppl 4):A468.
8. Gonzalez E, Sanchez-Rovira P, Jaen A, et al. Phase I study concomitant gemcitabine (G) with radiotherapy (RT) in stage III NSCLC (Abstract). Eur J Cancer 1999;35:A1054.
9. Vokes EE, Herndon JE, Crawford J, 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 2002;20:4191-4198.
10. Scalliet P, Goor C, Galdermans D, et al. Gemzar (gemcitabine) with thoracic radiotherapy: a phase II pilot tudy in chemonaive patients with advanced non small cell lung cancer (NSCLC) (Abstract). Proc Am Soc Clin Oncol 1998;17: 1923.
11. Fossella FV, Zinner RG, Komaki R, et al. Gemcitabine (G) with concurrent chest radiation (XRT) followed by consolidation chemotherapy with gemcitabine plus cisplatin (CDDP): a phase I trial for patients with stage III non-small cell lung cancer (NSCLC) (Abstract). Proc Am Soc Clin Oncol 2001;21:1243.
12. Socinski MA, Rosenman JG, Halle J, et al. Dose-escalating conformal thoracic radiation therapy with induction and concurrent carboplatin/paclitaxel in unresectable stage IIIA/B non small cell lung carcinoma: a modified phase I/II trial. Cancer 2001;92:1213-1223.
13. Gatzemeier U, Shepherd FA, Le Chevalier T, et al. Activity of gemcitabine in patients with non-small cell lung cancer: a multicentre, extended phase II study. Eur J Cancer 1996;32A:243-248.
14. Giaccone G, Smit EF, van Meerbeeck JP, et al. A phase I-II study of gemcitabine and paclitaxel in advanced non-small-cell lung cancer patients. Ann Oncol 2000;11:109-112.
15. Blackstock AW, Lightfoot H, Kwock L, et al. Gemcitabine: in vitro and in vivo evidence of its radiation sensitizing activity and studies using fluorine-19 magnetic resonance spectroscopy to determine the optimal dosing schedule - pre-clinical observations relevent to gemcitabine clinical trials (Abstract). Int J Radiat Oncol Biol Phys 1997;39:205.
16. Boven E, Schipper H, Erkelens CA, et al. The influence of the schedule and the dose of gemcitabine on the anti- tumour efficacy in experimental human cancer. Br J Cancer 1993;68:52-56.
17. Braakhuis BJ, Ruiz van Haperen VW, Boven E, et al. Scheduledependent antitumor effect of gemcitabine in an in vivo model system. Semin Oncol 1995;22:42-46.
18. Braakhuis BJ, van Dongen GA, Vermorken JB, et al. Preclinical in vivo activity of 2′,2′-difluorodeoxycytidine (Gemcitabine) against human head and neck cancer. Cancer Res 1991;51:211-214.
19. Fields MT, Eisbruch A, Normolle D, et al. Radiosensitization produced in vivo by once- vs. twice-weekly 2′2′-difluoro-2′-deoxycytidine (gemcitabine). Int J Radiat Oncol Biol Phys 2000;47:785-791.
20. Joschko MA, Webster LK, Groves J, et al. Enhancement of radiationinduced regrowth delay by gemcitabine in a human tumor xenograft model. Radiat Oncol Invest 1997;5:62-71.
21. Kanzawa F, Saijo N. In vitro interaction between gemcitabine and other anticancer drugs using a novel three-dimensional model. Semin Oncol 1997;24:8-16.
22. Lawrence TS, Chang EY, Hahn TM, et al. Radiosensitization of pancreatic cancer cells by 2′,2′-difluoro-2′-deoxycytidine. Int J Radiat Oncol Biol Phys 1996;34:867-872.
23. Lawrence TS, Chang EY, Hahn TM, et al. Delayed radiosensitization of human colon carcinoma cells after a brief exposure to 2′,2′- difluoro-2′-deoxycytidine (Gemcitabine). Clin Cancer Res 1997;3:777-782.
24. Mason KA, Milas L, Hunter NR, et al. Maximizing therapeutic gain with gencitabine and franctionated radiation. Int J Radiat Oncol Biol Phys 1999;44:1125-1135.
25. Milas L, Fujii T, Hunter N, et al. Enhancement of tumor radioresponse in vivo by gemcitabine. Cancer Res 1999;59:107-114.
26. Shewach DS, Hahn TM, Chang E, et al. Metabolism of 2′,2′- difluoro-2′-deoxycytidine and radiation sensitization of human colon carcinoma cells. Cancer Res 1994;54:3218-3223.
27. Shewach DS, Lawrence TS. Radiosensitization of human tumor cells by gemcitabine in vitro. Semin Oncol 1995;22:68-71.
28. Lund B, Ryberg M, Petersen PM, et al. Phase II study of gemcitabine (2′,2′-difluorodeoxycytidine) given as a twice weekly schedule to previously untreated patients with non-small cell lung cancer. Ann Oncol 1994;5:852-853.
29. Blackstock AW, Lesser GJ, Fletcher-Steede J, et al. Phase I study of twice-weekly gemcitabine and concurrent thoracic radiation for patients with locally advanced non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 2001;51:1281-1289.
30. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216.
31. Miller AB, Hogestraeten B, Staquet M, et al. Reporting results of cancer treatment. Cancer 1981;47:207-214.
32. Cancer Therapy Evaluation Program: Common Toxicity Criteria, version 2.0. Bethesda, MD: National Cancer Institute, March 1998.
33. Anton A, Diaz-Fernandez N, Gonzalez Larriba JL, et al. Phase II trial assessing the combination of gemcitabine and cisplatin in advanced non-small cell lung cancer (NSCLC). Lung Cancer 1998;22:139-148.
34. Gridelli C, Perrone F, Gallo C, et al. Single-agent gemcitabine as second-line treatment in patients with advanced non small cell lung cancer (NSCLC): a phase II trial. Anticancer Res 1999;19:4535-4538.
35. Grigorescu AC, Draghici IN, Nitipir C, et al. 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 2002;37:9-14.
36. Natale RB. Gemcitabine-containing regimens vs others in first-line treatment of NSCLC. Oncology (Huntingt) 2004;18:27-31.
37. Rocha Lima CM, Rizvi NA, Zhang C, et al. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol 2004;15:410-418.
38. Zhang L, Zhang Y, Li N, et al. [Gemcitabine plus cisplatin versus gemcitabine plus vinorelbine in treatment of advanced non-small cell lung cancer (NSCLC)]. Ai Zheng 2004;23:1455-1458.
39. Blanco R, Sole J, Nogue M, et al. Phase II multicentric study of concurrent chemoradiation (CCR) with biweekly gemcitabine after induction chemotherapy with cisplatin and gemcitabine in unresectable stage III non small cell lung cancer (NSCLC) (Abstract). Proc Am Soc Clin Oncol 2004;23:A7322.
40. Burmeister BH, Fielding DI, Ramsay JR, et al. A phase I study of moderate-dose radiation therapy and weekly gemcitabine in patients with locally advanced non-small cell lung cancer not suitable for radical chemoradiation therapy. Clin Oncol 2006;17:332-336.
41. van Putten JW, Price A, van der Leest AH, et al. A phase I study of gemcitabine with concurrent radiotherapy in stage III, locally advanced non-small cell lung cancer. Clin Cancer Res 2003;9:2472-2477.
42. Trodella L, Granone P, Valente S, et al. Phase I trial of weekly gemcitabine and concurrent radiotherapy in patients with inoperable non-small-cell lung cancer. J Clin Oncol 2002;20:804-810.
43. Bradley J, Movsas B. Radiation esophagitis: predictive factors and preventive strategies. Semin Radiat Oncol 2004;14:280-286.
44. Kahn D, Zhou S, Ahn SJ, et al. Anatomically-corrected dosimetric parameters may be better predictors for esophageal toxicity than are traditional CT-based metrics. Int J Radiat Biol Phys 2006;62:645-651.
45. Bhatia S, Hanna N, Ansari R, et al. A phase II study of weekly gemcitabine and paclitaxel in patients with previously untreated stage IIIb and IV non-small cell lung cancer. Lung Cancer 2002;38:73-77.
46. Smit EF, van Meerbeeck JP, Lianes P, et al. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group-EORTC 08975. J Clin Oncol 2003;21:3909-3917.
47. Zatloukal P, Kanitz E, Magyar P, et al. Gemcitabine in locally advanced and metastatic non-small cell lung cancer: the Central European phase II study. Lung Cancer 1998;22:243-250.
48. Dimopoulou I, Efstathiou E, Samakovli A, et al. A prospective study on lung toxicity in patients treated with gemcitabine and carboplatin: clinical, radiological and functional assessment. Ann Oncol 2004;15:1250-1255.
49. Divers SG, Spencer S, Carey D, et al. Phase I/IIa study of cisplatin and gemcitabine as induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine and paclitaxel for locally advanced nonsmall cell lung cancer. J Clin Oncol 2006;23:6664-6673.