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Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV

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Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV. / Meier, Werner; du Bois, Andreas; Rau, Jörn; Gropp-Meier, Martina; Baumann, Klaus; Huober, Jens; Wollschlaeger, Kerstin; Kreienberg, Rolf; Canzler, Ulrich; Schmalfeldt, Barbara; Wimberger, Pauline; Richter, Barbara; Schröder, Willibald; Belau, Antje; Stähle, Anne; Burges, Alexander; Sehouli, Jalid.

in: GYNECOL ONCOL, Jahrgang 126, Nr. 2, 08.2012, S. 236-40.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Meier, W, du Bois, A, Rau, J, Gropp-Meier, M, Baumann, K, Huober, J, Wollschlaeger, K, Kreienberg, R, Canzler, U, Schmalfeldt, B, Wimberger, P, Richter, B, Schröder, W, Belau, A, Stähle, A, Burges, A & Sehouli, J 2012, 'Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV', GYNECOL ONCOL, Jg. 126, Nr. 2, S. 236-40. https://doi.org/10.1016/j.ygyno.2012.04.050

APA

Meier, W., du Bois, A., Rau, J., Gropp-Meier, M., Baumann, K., Huober, J., Wollschlaeger, K., Kreienberg, R., Canzler, U., Schmalfeldt, B., Wimberger, P., Richter, B., Schröder, W., Belau, A., Stähle, A., Burges, A., & Sehouli, J. (2012). Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV. GYNECOL ONCOL, 126(2), 236-40. https://doi.org/10.1016/j.ygyno.2012.04.050

Vancouver

Meier W, du Bois A, Rau J, Gropp-Meier M, Baumann K, Huober J et al. Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV. GYNECOL ONCOL. 2012 Aug;126(2):236-40. https://doi.org/10.1016/j.ygyno.2012.04.050

Bibtex

@article{0f688b8f3f6747c8bfacee9b5f4687fe,
title = "Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV",
abstract = "OBJECTIVES: This study evaluates whether a molecular targeted therapy with the farnesyltransferase inhibitor lonafarnib added to standard chemotherapy in first-line treatment of advanced ovarian cancer (OC) could improve progression-free (PFS) and overall survival (OS).PATIENTS AND METHODS: We performed a prospective randomized phase II study to compare standard therapy carboplatin (C; AUC 5) and paclitaxel (T; 175 mg/m(2)) in primary advanced OC with or without lonafarnib (L). Lonafarnib was given in a dose of 100mg orally twice a day during chemotherapy and was increased afterwards to 200mg up to six months as a maintenance therapy.RESULTS: 105 patients were recruited (53 patients were randomized to receive LTC, 52 to TC). Hematologic toxicity was similar in both arms. Grade 3 and 4 non-hematological toxicity, occurred significantly more often with LTC (23% versus 4%, p=0.005) and was associated with a higher dropout rate. PFS and OS were not significantly different among both arms. The LTC arm showed inferiority in the stratum with residual tumor of more than 1cm: median PFS was 11.5 months (95% CI: 7.4-14.2) compared with 16.4 (95% CI: 10.3-40.4) for TC (p=0.0141; HR=0.36 (95% CI: 0.15-0.84)) with median OS 20.6 months (95% CI: 13.1-31.0) and 43.4 months (95% CI: 15.7-) for the TC arm (p=0.012; HR=0.32 (95% CI: 0.13-0.8)).CONCLUSION: The addition of lonafarnib did not improve PFS or OS. Patients with a residual tumor of more than 1cm had significantly shorter PFS and OS. Incorporation of lonafarnib into future studies for primary therapy of OC is not recommended.",
keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Disease-Free Survival, Female, Humans, Middle Aged, Neoplasm Staging, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Paclitaxel, Piperidines, Prospective Studies, Pyridines, Survival Analysis, Young Adult",
author = "Werner Meier and {du Bois}, Andreas and J{\"o}rn Rau and Martina Gropp-Meier and Klaus Baumann and Jens Huober and Kerstin Wollschlaeger and Rolf Kreienberg and Ulrich Canzler and Barbara Schmalfeldt and Pauline Wimberger and Barbara Richter and Willibald Schr{\"o}der and Antje Belau and Anne St{\"a}hle and Alexander Burges and Jalid Sehouli",
note = "Copyright {\textcopyright} 2012 Elsevier Inc. All rights reserved.",
year = "2012",
month = aug,
doi = "10.1016/j.ygyno.2012.04.050",
language = "English",
volume = "126",
pages = "236--40",
journal = "GYNECOL ONCOL",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "2",

}

RIS

TY - JOUR

T1 - Randomized phase II trial of carboplatin and paclitaxel with or without lonafarnib in first-line treatment of epithelial ovarian cancer stage IIB-IV

AU - Meier, Werner

AU - du Bois, Andreas

AU - Rau, Jörn

AU - Gropp-Meier, Martina

AU - Baumann, Klaus

AU - Huober, Jens

AU - Wollschlaeger, Kerstin

AU - Kreienberg, Rolf

AU - Canzler, Ulrich

AU - Schmalfeldt, Barbara

AU - Wimberger, Pauline

AU - Richter, Barbara

AU - Schröder, Willibald

AU - Belau, Antje

AU - Stähle, Anne

AU - Burges, Alexander

AU - Sehouli, Jalid

N1 - Copyright © 2012 Elsevier Inc. All rights reserved.

PY - 2012/8

Y1 - 2012/8

N2 - OBJECTIVES: This study evaluates whether a molecular targeted therapy with the farnesyltransferase inhibitor lonafarnib added to standard chemotherapy in first-line treatment of advanced ovarian cancer (OC) could improve progression-free (PFS) and overall survival (OS).PATIENTS AND METHODS: We performed a prospective randomized phase II study to compare standard therapy carboplatin (C; AUC 5) and paclitaxel (T; 175 mg/m(2)) in primary advanced OC with or without lonafarnib (L). Lonafarnib was given in a dose of 100mg orally twice a day during chemotherapy and was increased afterwards to 200mg up to six months as a maintenance therapy.RESULTS: 105 patients were recruited (53 patients were randomized to receive LTC, 52 to TC). Hematologic toxicity was similar in both arms. Grade 3 and 4 non-hematological toxicity, occurred significantly more often with LTC (23% versus 4%, p=0.005) and was associated with a higher dropout rate. PFS and OS were not significantly different among both arms. The LTC arm showed inferiority in the stratum with residual tumor of more than 1cm: median PFS was 11.5 months (95% CI: 7.4-14.2) compared with 16.4 (95% CI: 10.3-40.4) for TC (p=0.0141; HR=0.36 (95% CI: 0.15-0.84)) with median OS 20.6 months (95% CI: 13.1-31.0) and 43.4 months (95% CI: 15.7-) for the TC arm (p=0.012; HR=0.32 (95% CI: 0.13-0.8)).CONCLUSION: The addition of lonafarnib did not improve PFS or OS. Patients with a residual tumor of more than 1cm had significantly shorter PFS and OS. Incorporation of lonafarnib into future studies for primary therapy of OC is not recommended.

AB - OBJECTIVES: This study evaluates whether a molecular targeted therapy with the farnesyltransferase inhibitor lonafarnib added to standard chemotherapy in first-line treatment of advanced ovarian cancer (OC) could improve progression-free (PFS) and overall survival (OS).PATIENTS AND METHODS: We performed a prospective randomized phase II study to compare standard therapy carboplatin (C; AUC 5) and paclitaxel (T; 175 mg/m(2)) in primary advanced OC with or without lonafarnib (L). Lonafarnib was given in a dose of 100mg orally twice a day during chemotherapy and was increased afterwards to 200mg up to six months as a maintenance therapy.RESULTS: 105 patients were recruited (53 patients were randomized to receive LTC, 52 to TC). Hematologic toxicity was similar in both arms. Grade 3 and 4 non-hematological toxicity, occurred significantly more often with LTC (23% versus 4%, p=0.005) and was associated with a higher dropout rate. PFS and OS were not significantly different among both arms. The LTC arm showed inferiority in the stratum with residual tumor of more than 1cm: median PFS was 11.5 months (95% CI: 7.4-14.2) compared with 16.4 (95% CI: 10.3-40.4) for TC (p=0.0141; HR=0.36 (95% CI: 0.15-0.84)) with median OS 20.6 months (95% CI: 13.1-31.0) and 43.4 months (95% CI: 15.7-) for the TC arm (p=0.012; HR=0.32 (95% CI: 0.13-0.8)).CONCLUSION: The addition of lonafarnib did not improve PFS or OS. Patients with a residual tumor of more than 1cm had significantly shorter PFS and OS. Incorporation of lonafarnib into future studies for primary therapy of OC is not recommended.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Carboplatin

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Middle Aged

KW - Neoplasm Staging

KW - Neoplasms, Glandular and Epithelial

KW - Ovarian Neoplasms

KW - Paclitaxel

KW - Piperidines

KW - Prospective Studies

KW - Pyridines

KW - Survival Analysis

KW - Young Adult

U2 - 10.1016/j.ygyno.2012.04.050

DO - 10.1016/j.ygyno.2012.04.050

M3 - SCORING: Journal article

C2 - 22564713

VL - 126

SP - 236

EP - 240

JO - GYNECOL ONCOL

JF - GYNECOL ONCOL

SN - 0090-8258

IS - 2

ER -