Phase II study of maintenance sunitinib following irinotecan and carboplatin as first-line treatment for patients with extensive-stage small-cell lung cancer

Lung Cancer

Volumn 77, Issue 2, 2012, Pages 359-364

  Spigel, David R ^a,b   Greco, F Anthony ^a,b   Rubin, Mark S ^a,c   Shipley, Dianna ^a,b   Thompson, Dana S ^a,b   Lubiner, Eric T ^a,c   Eakle, Janice F ^a,c   Quinn, Raven ^a   Burris, Howard A ^a,b   Hainsworth, John D ^a,b  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b PLLC   (United States)

^c Florida Cancer Specialists   (United States)

Author keywords

Carboplatin; First line; Irinotecan; Maintenance; Small cell lung cancer; Sunitinib

Indexed keywords

CARBOPLATIN; IRINOTECAN; SUNITINIB;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BLEEDING; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG DOSE SEQUENCE; DRUG FEVER; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; HYPERTENSION; HYPONATREMIA; LUNG SMALL CELL CANCER; MAINTENANCE THERAPY; MALE; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; POST TREATMENT SURVIVAL; PRIORITY JOURNAL; THROMBOCYTOPENIA; THROMBOEMBOLISM; TREATMENT DURATION; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CARBOPLATIN; DISEASE PROGRESSION; FEMALE; HUMANS; INDOLES; INDUCTION CHEMOTHERAPY; LUNG NEOPLASMS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; NEOPLASM STAGING; PYRROLES; SMALL CELL LUNG CARCINOMA; TREATMENT OUTCOME;

EID: 84863781482     PISSN: 01695002     EISSN: 18728332     Source Type: Journal    
DOI: 10.1016/j.lungcan.2012.03.009     Document Type: Article

References (44)

1. Schmittel A., Fischer von Weikersthal L., Sebastian M., Martus P., Schulze K., Hortig P., et al. A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer. Ann Oncol 2006, 17(4):663-667.
2. Noda K., Nishiwaki Y., Kawahara M., Negoro S., Sugiura T., Yokoyama A., et al. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 2002, 346(2):85-91. [see comment].
3. Natale R.B., Lara P.N., Chansky K., Crowley J.J., Jett J.R., Carleton J.E., et al. S0124: a randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). J Clin Oncol (Meeting Abstracts) 2008, 26(15 Suppl.):7512.
4. Kinoshita A., Fukuda M., Soda H., Nagashima S., Fukuda M., Takatani H., et al. Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer. Brit J Cancer 2006, 94(9):1267-1271.
5. Hermes A., Bergman B., Bremnes R., Ek L., Fluge S., Sederholm C., et al. Irinotecan plus carboplatin versus oral etoposide plus carboplatin in extensive small-cell lung cancer: a randomized phase III trial. J Clin Oncol 2008, 26(26):4261-4267.
6. Hanna N., Bunn P.A., Langer C., Einhorn L., Guthrie T., Beck T., et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol 2006, 24(13):2038-2043.
7. Eckardt J.R., von Pawel J., Papai Z., Tomova A., Tzekova V., Crofts T.E., et al. Open-label, multicenter, randomized, phase III study comparing oral topotecan/cisplatin versus etoposide/cisplatin as treatment for chemotherapy-naive patients with extensive-disease small-cell lung cancer. J Clin Oncol 2006, 24(13):2044-2051. [see comment].
8. Chen G., Huynh M., Fehrenbacher L., West H., Lara P.N., Yavorkovsky L.L., et al. Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer. J Clin Oncol 2009, 27(9):1401-1404.
9. Govindan R., Page N., Morgensztern D., Read W., Tierney R., Vlahiotis A., et al. Changing epidemiology of small-cell lung cancer in the United States over the last 30years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 2006, 24:4539-4544.
10. Mall J.W., Schwenk W., Philipp A.W., Meyer-Kipker C., Mall W., Muller J., et al. Serum vascular endothelial growth factor levels correlate better with tumour stage in small cell lung cancer than albumin: neuron-specific enolase or lactate dehydrogenase. Respirology 2002, 7(2):99-102.
11. Lund E.L., Thorsen C., Pedersen M.W., Junker N., Kristjansen P.E. Relationship between vessel density and expression of vascular endothelial growth factor and basic fibroblast growth factor in small cell lung cancer in vivo and in vitro. Clin Cancer Res 2000, 6(11):4287-4291.
12. Fontanini G., Faviana P., Lucchi M., Boldrini L., Mussi A., Camacci T., et al. A high vascular count and overexpression of vascular endothelial growth factor are associated with unfavourable prognosis in operated small cell lung carcinoma. Brit J Cancer 2002, 86(4):558-563.
13. Mendel D.B., Laird A.D., Xin X., Louie S.G., Christensen J.G., Li G., et al. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 2003, 9(1):327-337.
14. Socinski M.A., Scappaticci F.A., Samant M., Kolb M.M., Kozloff M.F. Safety and efficacy of combining sunitinib with bevacizumab+paclitaxel/carboplatin in non-small cell lung cancer. J Thorac Oncol: Off Publ Int Assoc Stud Lung Cancer 2010, 5(3):354-360.
15. Novello S., Scagliotti G.V., Rosell R., Socinski M.A., Brahmer J., Atkins J., et al. Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Brit J Cancer 2009, 101(9):1543-1548.
16. Socinski M.A. The current status and evolving role of sunitinib in non-small cell lung cancer. J Thorac Oncol: Off Publ Int Assoc Stud Lung Cancer 2008, 3(6 Suppl 2):S119-S123.
17. Socinski M.A., Novello S., Brahmer J.R., Rosell R., Sanchez J.M., Belani C.P., et al. Multicenter: phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. J Clin Oncol 2008, 26(4):650-656.
18. Qvortrup C., Jensen B.V., Jorgensen T.L., Nielsen D., Bjerregaard J.K., Pfeiffer P. Addition of sunitinib to cetuximab and irinotecan in patients with heavily pre-treated advanced colorectal cancer. Acta Oncol 2010, 49(6):833-836.
19. Friedman H.S., Vredenburgh J.J., Desjardins A., Janney D.E., Peters K.B., Friedman A.H., et al. A phase I study of sunitinib plus irinotecan in the treatment of patients with recurrent malignant glioma. J Clin Oncol (Meeting Abstracts) 2009, 27(15S):e13024.
20. Grisanti S., Pedersini R., Ferrari V.D., Liserre R., Consoli F., Poliani L., et al. Phase II study of sunitinib and irinotecan in patients with recurrent high-grade glioma (HGG). J Clin Oncol (Meeting Abstracts) 2010, 28(15 Suppl.):e12537.
21. Heath E.I., Blumenschein G.R., Cohen R.B., LoRusso P.M., LoConte N., Kim S.T., et al. Sunitinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors: updated phase I study results. J Clin Oncol (Meeting Abstracts) 2009, 27(15S):e14509.
22. Spigel D.R., Hainsworth J.D., Yardley D.A., Raefsky E., Patton J., Peacock N., et al. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol 2010, 28(1):43-48.
23. Ready N., Dudek A.Z., Wang X.F., Graziano S., Green M.R., Vokes E.E. CALGB 30306: a phase II study of cisplatin (C), irinotecan (I) and bevacizumab (B) for untreated extensive stage small cell lung cancer (ES-SCLC). J Clin Oncol (Meeting Abstracts) 2007, 25(18 Suppl.):7563.
24. Spigel D.R., Greco F.A., Zubkus J.D., Murphy P.B., Saez R.A., Farley C., et al. Phase II trial of irinotecan: carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol: Off Publ Int Assoc Stud Lung Cancer 2009, 4(12):1555-1560.
25. Hirose T., Horichi N., Ohmori T., Ogura K., Hosaka T., Ando K., et al. Phase II study of irinotecan and carboplatin in patients with the refractory or relapsed small cell lung cancer. Lung Cancer 2003, 40(3):333-338.
26. Kinoshita A., Fukuda M., Soda H., Nagashima S., Fukuda M., Takatani H., et al. Phase II study of irinotecan combined with carboplatin in previously untreated small-cell lung cancer. Br J Cancer 2006, 94(9):1267-1271.
27. Schmittel A., Fischer von Weikersthal L., Sebastian M., Martus P., Schulze K., Hortig P., et al. A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer. Ann Oncol 2006, 17(4):663-667.
28. Spigel D.R., Greco F.A. Evolving role of irinotecan in small-cell lung cancer. Clin Adv Hematol Oncol 2003, 1(8):482-485.
29. Spigel D.R., Hainsworth J.D., Simons L., Meng C., Burris H.A., Yardley D.A., et al. Irinotecan, carboplatin, and imatinib in untreated extensive-stage small-cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network. J Thorac Oncol 2007, 2(9):854-861.
30. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000, 92:205-216.
31. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. 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 2000, 92(3):205-216.
32. Calvert A.H., Newell D.R., Gumbrell L.A., O'Reilly S., Burnell M., Boxall F.E., et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989, 7(11):1748-1756.
33. Kaplan E., Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 5.3:457-481.
34. Slotman B., Faivre-Finn C., Kramer G., Rankin E., Snee M., Hatton M., et al. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med 2007, 357(7):664-672.
35. Rini B.I., Halabi S., Rosenberg J.E., Stadler W.M., Vaena D.A., Archer L., et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol 2010, 28(13):2137-2143.
36. Sandler A., Gray R., Perry M.C., Brahmer J., Schiller J.H., Dowlati A., et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006, 355(24):2542-2550.
37. Hurwitz H., Fehrenbacher L., Novotny W., Cartwright T., Hainsworth J., Heim W., et al. Bevacizumab plus irinotecan: fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004, 350(23):2335-2342.
38. Friedman H.S., Prados M.D., Wen P.Y., Mikkelsen T., Schiff D., Abrey L.E., et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol 2009, 27(28):4733-4740.
39. Burger R.A., Brady M.F., Bookman M.A., Walker J.L., Homesley H.D., Fowler J., et al. Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): a Gynecologic Oncology Group study. J Clin Oncol (Meeting Abstracts) 2010, 28(18 Suppl.). p. LBA1.
40. Reddy S.K., Morse M.A., Hurwitz H.I., Bendell J.C., Gan T.J., Hill S.E., et al. Addition of bevacizumab to irinotecan- and oxaliplatin-based preoperative chemotherapy regimens does not increase morbidity after resection of colorectal liver metastases. J Am Coll Surg 2008, 206(1):96-106.
41. Horn L., Dahlberg S.E., Sandler A.B., Dowlati A., Moore D.F., Murren J.R., et al. Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer: Eastern Cooperative Oncology Group Study E3501. J Clin Oncol 2009, 27(35):6006-6011.
42. Spigel D., Townley P., Waterhouse D., Fang L., Adiguzel I., Huang J., et al. SALUTE: a placebo-controlled, double-blind, multicenter, randomized, phase ii study of bevacizumab in previously untreated extensive-stage small cell lung cancer (SCLC). 13th world conference on lung cancer 2009.
43. Kozloff M., Chuang E., Starr A., Gowland P.A., Cataruozolo P.E., Collier M., et al. An exploratory study of sunitinib plus paclitaxel as first-line treatment for patients with advanced breast cancer. Ann Oncol 2010, 21(7):1436-1441.
44. Ready N., Dunphy F., Pang H., Heinze R., Crawford J., Vokes E.E. Combination chemotherapy with sunitinib (IND 74019; NSC 736511) for untreated extensive-stage small cell lung cancer (SCLC): CALGB 30504 phase IB safety results. J Clin Oncol (Meeting Abstracts) 2010, 28(15 Suppl.):7056.