Dose escalation of once weekly oral vinorelbine concurrent with weekly split dose hypofractionated chest radiation for palliation of advanced non-small cell lung cancer: A phase I/II study

American Journal of the Medical Sciences

Volumn 341, Issue 6, 2011, Pages 454-459

  Schwarzenberger, Paul ^a   Fariss, Anna ^b   Linares, Louis ^a   Nedzi, Lucien ^c   Salazar, Omar M ^d  

^a East Jefferson Hospital   (United States)

^b DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^c UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^d Oakwood Healthcare Inc   (United States)

Author keywords

Chemoradiation; Hypofractionated chest radiation; Non small cell lung cancer; Palliation

Indexed keywords

ANTINEOPLASTIC AGENT; NAVELBINE; PLATINUM DERIVATIVE; RECOMBINANT COLONY STIMULATING FACTOR; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SEROTONIN 3 ANTAGONIST;

ADULT; ADVANCED CANCER; AGED; ANEMIA; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER PALLIATIVE THERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONFERENCE PAPER; CONSTIPATION; DIARRHEA; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROLYTE DISTURBANCE; ERYTHROCYTE TRANSFUSION; ESOPHAGITIS; FATIGUE; FEMALE; HUMAN; HYPOFRACTIONATED CHEST IRRADIATION; KIDNEY DYSFUNCTION; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NAUSEA; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; RADIATION DOSE FRACTIONATION; RADIATION FIELD; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE;

EID: 79958110951     PISSN: 00029629     EISSN: 15382990     Source Type: Journal    
DOI: 10.1097/MAJ.0b013e3182127b3f     Document Type: Conference Paper

References (37)

1. Schwarzenberger P, Theodossiou C, Barron S, et al. Dose escalation of docetaxel concomitant with hypofractionated, once weekly chest radiotherapy for non-small-cell lung cancer: a phase I study. Am J Clin Oncol 2004;27:395-9. (Pubitemid 39045251)
2. Briasoulis E, Karavasilis V, Anastasopoulos D, et al. Weekly do-cetaxel in minimally pretreated cancer patients: a dose-escalation study focused on feasibility and cumulative toxicity of long-term administra-tion. Ann Oncol 1999;10:701-6. (Pubitemid 29342376)
3. Hainsworth JD, Burris HA, Greco FA. Weekly administration of docetaxel (Taxotere): summary ofclinical data. Semin Oncol 1999;26: 19-24. (Pubitemid 29368113)
4. Mauer AM, Masters GA, Haraf DJ, et al. Phase I study of docetaxel with concomitant thoracic radiation therapy. J Clin Oncol 1998;16:159-64. (Pubitemid 28041594)
5. Schaake-Koning C, van den Bogaert W, Dalesio O, et al. Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer. N Engl J Med 1992;326:524-30.
6. Wakelee H, Kernstine K, Vokes E, et al. Cooperative group research efforts in lung cancer 2008: focus on advanced-stage non-small-cell lung cancer. Clin Lung Cancer 2008;9:346-51.
7. Al mamgani A, Tans L, Van rooij PH, et al. Hypofractionated radiotherapy denoted as the "Christie scheme": an effective means of palliating patients with head and neck cancers not suitable for curative treatment. Acta Oncol 2009;48:562-70.
8. Nedzi LA. The implementation ofablative hypofractionated radiotherapy for stereotactic treatments in the brain and body: observations on efficacy and toxicity in clinical practice. Semin Radiat Oncol 2008;18:265-72.
9. Gridelli C, Maione P, Rossi A. Treatment ofstage I-III non-small-cell lung cancer in the elderly. Oncology 2006;20:373-80. (Pubitemid 46940194)
10. Abratt RP, Bogart JA, Hunter A. Hypofractionated irradiation for non-small cell lung cancer. Lung Cancer 2002;36:225-33. (Pubitemid 34497119)
11. Slawson RG, Salazar OM, Poussin-Rosillo H, et al. Once-a-week vs conventional daily radiation treatment for lung cancer: final report. Int J Radiat Oncol Biol Phys 1988;15:61-8.
12. Cross CK, Berman S, Buswell L, et al. Prospective study ofpalliative hypofractionated radiotherapy (8.5 Gy x 2) for patients with symptomatic non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 2004;58:1098-105. (Pubitemid 38314791)
13. Gridelli C. The ELVIS trial: a phase III study ofsingle-agent vinore-lbine as first-line treatment in elderly patients with advanced non-small cell lung cancer. Elderly Lung Cancer Vinorelbine Italian Study. Oncologist 2001;6(suppl 1):4-7. (Pubitemid 32155180)
14. Gridelli C, Perrone F, Gallo C, et al. Vinorelbine is well tolerated and active in the treatment ofelderly patients with advanced non-small cell lung cancer. A two-stage phase II study. Eur J Cancer 1997;33:392-7. (Pubitemid 27168064)
15. Gridelli C, Hainsworth J. Meeting the chemotherapy needs ofelderly and poor performance status patients with NSCLC. Lung Cancer 2002;38(suppl 4):37-41.
16. Simoens C, Lardon F, Pauwels B, et al. Comparative study of the radiosensitizing and cell cycle effects ofvinflunine and vinorelbine, in vitro. BMC Cancer 2008;8:65.
17. Sarkar SK, Patra NB, Goswami J, et al. Comparative study of efficacy and toxicities of cisplatin vs vinorelbine as radiosensitisers in locally advanced head and neck cancer. J Laryngol Otol 2008; 122:188-92. (Pubitemid 351650836)
18. Fukuoka K, Arioka H, Iwamoto Y, et al. Mechanism ofvinorelbine-induced radiosensitization of human small cell lung cancer cells. Can-cer Chemother Pharmacol 2002;49:385-90. (Pubitemid 34439339)
19. Teyssier F, Bay JO, Dionet C, et al. [Cell cycle regulation after exposure to ionizing radiation]. Bull Cancer 1999;86:345-57. (Pubitemid 29230826)
20. Marty M, Fumoleau P, Adenis A, et al. Oral vinorelbine pharmaco-kinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol 2001;12:1643-9. (Pubitemid 34070598)
21. Jassem J, Ramlau R, Karnicka-Mlodkowska H, et al. A multicenter randomized phase II study of oral vs. intravenous vinorelbine in advanced non-small-cell lung cancer patients. Ann Oncol 2001;12:1375-81. (Pubitemid 33100241)
22. Bonneterre J, Chevalier B, Focan C, et al. Phase I and pharmacoki-netic study of weekly oral therapy with vinorelbine in patients with advanced breast cancer (ABC). Ann Oncol 2001;12:1683-91. (Pubitemid 34105657)
23. Depierre A, Freyer G, Jassem J, et al. Oral vinorelbine: feasibility and safety profile. Ann Oncol 2001;12:1677-81. (Pubitemid 34105656)
24. Bezjak A, Dixon P, Brundage M, et al. Randomized phase III trial of single versus fractionated thoracic radiation in the palliation of patients with lung cancer (NCIC CTG SC. 15). Int J Radiat Oncol Biol Phys 2002;54:719-28.
25. Belani CP, Wang W, Johnson DH, et al. Phase III study of the Eastern Cooperative Oncology Group (ECOG 2597): induction chemotherapy followed by either standard thoracic radiotherapy or hyperfractionated accelerated radiotherapy for patients with unresectable stage IIIA and B non-small-cell lung cancer. J Clin Oncol 2005;23:3760-7.
26. Bourhis J, Overgaard J, Audry H, et al. Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis. Lancet 2006;368:843-54. (Pubitemid 44292807)
27. Murray N, Turrisi AT III. A review of first-line treatment for small-cell lung cancer. J Thorac Oncol 2006;1:270-8. (Pubitemid 47181446)
28. Sonveaux P. Provascular strategy: targeting functional adaptations of mature blood vessels in tumors to selectively influence the tumor vascular reactivity and improve cancer treatment. Radiother Oncol 2008;86:300-13.
29. De Ruysscher D, Wanders R, van Haren E, et al. HI-CHART: a phase I/II study on the feasibility of high-dose continuous hyperfrac-tionated accelerated radiotherapy in patients with inoperable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 2008;71:132-8. (Pubitemid 351491406)
30. Graham MV, Pajak TE, Herskovic AM, et al. Phase I/II study of treatment of locally advanced (T3/T4) non-oat cell lung cancer with concomitant boost radiotherapy by the Radiation Therapy Oncology Group (RTOG 83-12): long-term results. Int J Radiat Oncol Biol Phys 1995;31:819-25.
31. Lam TK, Leung DT. More on simplified calculation ofbody-surface area. N Engl J Med 1988;318:1130. (Pubitemid 18098619)
32. Eisenhauer EA, O'Dwyer PJ, Christian M, et al. Phase I clinical trial design in cancer drug development. J Clin Oncol 2000;18:684-92. (Pubitemid 30078550)
33. Machtay M, Hsu C, Komaki R, et al. Effect ofoverall treatment time on outcomes after concurrent chemoradiation for locally advanced non-small-cell lung carcinoma: analysis of the Radiation Therapy Oncology Group (RTOG) experience. Int J Radiat Oncol Biol Phys 2005;63:667-71. (Pubitemid 41400050)
34. Vokes EE, Rosenberg RK, Jahanzeb M, et al. Multicenter phase II study of weekly oral vinorelbine for stage IV non-small-cell lung cancer. J Clin Oncol 1995;13:637-44.
35. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353:123-32. (Pubitemid 41058344)
36. Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22:1589-97. (Pubitemid 41079796)
37. Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multi-centre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005;366:1527-37. (Pubitemid 41540110)