Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer: A New York Cancer Consortium Study

Dennis Yi-Shin Kuo, Stephanie V. Blank, Paul J. Christos, Mimi Kim, Thomas A. Caputo, Bhavana Pothuri, Dawn Hershman, Noah Goldman, Percy S. Ivy, Carolyn D. Runowicz, Franco Muggia, Gary L. Goldberg, Mark H. Einstein

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Objective: Survival in women with recurrent or metastatic cervical cancer remains poor. More effective and less toxic regimens are needed. Cisplatin is an effective radiosensitizer, but its single agent activity in recurrent cervical cancer, especially after prior cisplatin exposure, is disappointing, with a response rate of only 13%. Oxaliplatin has preclinical activity in cisplatin-resistant tumors and may have synergic activity when combined with paclitaxel. Our objective is to determine the efficacy and toxicity of paclitaxel and oxaliplatin in patients with recurrent or metastatic cervical cancer. Methods: Patients with histologic confirmation of primary metastatic or recurrent cervical cancer not amenable to surgical management were eligible. Treatment consisted of paclitaxel 175 mg/m2 IV and oxaliplatin 130 mg/m2 IV every 21 days. The primary endpoints were toxicity, recorded every cycle, and response, determined by RECIST criteria and were assessed every 9 weeks, with subsequent confirmation as required. Sample size determinations were made using a Simon's two-stage design with a projected overall response proportion of 13% with cisplatin alone. Survival rates were calculated with Kaplan-Meier methods. Results: Of the 35 patients enrolled, 32 were evaluable. The median age was 56 (27-78); 30 had had prior radiation (23 concomitant with cisplatin). Patients completed a mean of 4.2 cycles (1-11). There were 2 complete and 5 partial responses for a total response rate of 7/32 (22%; 95% CI: 9.3%-40.0%). Eight patients had stable disease for an overall clinical benefit rate of 15/32 (47%; 95% CI: 29.1%-65.3%). The mean time to best response was 13.5 weeks (95% CI: 10.6, 16.4). The mean progression-free survival was 21 weeks (95% CI: 14.7, 27.2) and mean overall survival was 52 weeks (95% CI: 39.4, 64.8). A total of 135 cycles were administered. There were 28 (20.1%) grade 3/4 hematologic toxicities and 46 (34.1%) grade 3/4 non-hematologic toxicities, which were predominantly sensory neuropathy. There were 13 treatment delays, 4 dose reductions, and no treatment-related deaths. Conclusions: The combination of paclitaxel and oxaliplatin is an effective regimen in patients with recurrent or persistent cervical cancer including a majority previously exposed to cisplatin. Further study and comparison with other platinum-based regimens is warranted.

Original languageEnglish (US)
Pages (from-to)442-446
Number of pages5
JournalGynecologic Oncology
Volume116
Issue number3
DOIs
StatePublished - Mar 2010

Fingerprint

oxaliplatin
Paclitaxel
Uterine Cervical Neoplasms
Cisplatin
Neoplasms
Survival
Poisons
Platinum
Sample Size
Disease-Free Survival
Therapeutics
Survival Rate

Keywords

  • Oxaliplatin
  • Paclitaxel
  • Recurrent cervical cancer
  • Response
  • Toxicity

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer : A New York Cancer Consortium Study. / Kuo, Dennis Yi-Shin; Blank, Stephanie V.; Christos, Paul J.; Kim, Mimi; Caputo, Thomas A.; Pothuri, Bhavana; Hershman, Dawn; Goldman, Noah; Ivy, Percy S.; Runowicz, Carolyn D.; Muggia, Franco; Goldberg, Gary L.; Einstein, Mark H.

In: Gynecologic Oncology, Vol. 116, No. 3, 03.2010, p. 442-446.

Research output: Contribution to journalArticle

Kuo, DY-S, Blank, SV, Christos, PJ, Kim, M, Caputo, TA, Pothuri, B, Hershman, D, Goldman, N, Ivy, PS, Runowicz, CD, Muggia, F, Goldberg, GL & Einstein, MH 2010, 'Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer: A New York Cancer Consortium Study', Gynecologic Oncology, vol. 116, no. 3, pp. 442-446. https://doi.org/10.1016/j.ygyno.2009.10.082
Kuo, Dennis Yi-Shin ; Blank, Stephanie V. ; Christos, Paul J. ; Kim, Mimi ; Caputo, Thomas A. ; Pothuri, Bhavana ; Hershman, Dawn ; Goldman, Noah ; Ivy, Percy S. ; Runowicz, Carolyn D. ; Muggia, Franco ; Goldberg, Gary L. ; Einstein, Mark H. / Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer : A New York Cancer Consortium Study. In: Gynecologic Oncology. 2010 ; Vol. 116, No. 3. pp. 442-446.
@article{30d4c3c11f434dc8a34ca64bbfde2fbe,
title = "Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer: A New York Cancer Consortium Study",
abstract = "Objective: Survival in women with recurrent or metastatic cervical cancer remains poor. More effective and less toxic regimens are needed. Cisplatin is an effective radiosensitizer, but its single agent activity in recurrent cervical cancer, especially after prior cisplatin exposure, is disappointing, with a response rate of only 13{\%}. Oxaliplatin has preclinical activity in cisplatin-resistant tumors and may have synergic activity when combined with paclitaxel. Our objective is to determine the efficacy and toxicity of paclitaxel and oxaliplatin in patients with recurrent or metastatic cervical cancer. Methods: Patients with histologic confirmation of primary metastatic or recurrent cervical cancer not amenable to surgical management were eligible. Treatment consisted of paclitaxel 175 mg/m2 IV and oxaliplatin 130 mg/m2 IV every 21 days. The primary endpoints were toxicity, recorded every cycle, and response, determined by RECIST criteria and were assessed every 9 weeks, with subsequent confirmation as required. Sample size determinations were made using a Simon's two-stage design with a projected overall response proportion of 13{\%} with cisplatin alone. Survival rates were calculated with Kaplan-Meier methods. Results: Of the 35 patients enrolled, 32 were evaluable. The median age was 56 (27-78); 30 had had prior radiation (23 concomitant with cisplatin). Patients completed a mean of 4.2 cycles (1-11). There were 2 complete and 5 partial responses for a total response rate of 7/32 (22{\%}; 95{\%} CI: 9.3{\%}-40.0{\%}). Eight patients had stable disease for an overall clinical benefit rate of 15/32 (47{\%}; 95{\%} CI: 29.1{\%}-65.3{\%}). The mean time to best response was 13.5 weeks (95{\%} CI: 10.6, 16.4). The mean progression-free survival was 21 weeks (95{\%} CI: 14.7, 27.2) and mean overall survival was 52 weeks (95{\%} CI: 39.4, 64.8). A total of 135 cycles were administered. There were 28 (20.1{\%}) grade 3/4 hematologic toxicities and 46 (34.1{\%}) grade 3/4 non-hematologic toxicities, which were predominantly sensory neuropathy. There were 13 treatment delays, 4 dose reductions, and no treatment-related deaths. Conclusions: The combination of paclitaxel and oxaliplatin is an effective regimen in patients with recurrent or persistent cervical cancer including a majority previously exposed to cisplatin. Further study and comparison with other platinum-based regimens is warranted.",
keywords = "Oxaliplatin, Paclitaxel, Recurrent cervical cancer, Response, Toxicity",
author = "Kuo, {Dennis Yi-Shin} and Blank, {Stephanie V.} and Christos, {Paul J.} and Mimi Kim and Caputo, {Thomas A.} and Bhavana Pothuri and Dawn Hershman and Noah Goldman and Ivy, {Percy S.} and Runowicz, {Carolyn D.} and Franco Muggia and Goldberg, {Gary L.} and Einstein, {Mark H.}",
year = "2010",
month = "3",
doi = "10.1016/j.ygyno.2009.10.082",
language = "English (US)",
volume = "116",
pages = "442--446",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",

}

TY - JOUR

T1 - Paclitaxel plus oxaliplatin for recurrent or metastatic cervical cancer

T2 - A New York Cancer Consortium Study

AU - Kuo, Dennis Yi-Shin

AU - Blank, Stephanie V.

AU - Christos, Paul J.

AU - Kim, Mimi

AU - Caputo, Thomas A.

AU - Pothuri, Bhavana

AU - Hershman, Dawn

AU - Goldman, Noah

AU - Ivy, Percy S.

AU - Runowicz, Carolyn D.

AU - Muggia, Franco

AU - Goldberg, Gary L.

AU - Einstein, Mark H.

PY - 2010/3

Y1 - 2010/3

N2 - Objective: Survival in women with recurrent or metastatic cervical cancer remains poor. More effective and less toxic regimens are needed. Cisplatin is an effective radiosensitizer, but its single agent activity in recurrent cervical cancer, especially after prior cisplatin exposure, is disappointing, with a response rate of only 13%. Oxaliplatin has preclinical activity in cisplatin-resistant tumors and may have synergic activity when combined with paclitaxel. Our objective is to determine the efficacy and toxicity of paclitaxel and oxaliplatin in patients with recurrent or metastatic cervical cancer. Methods: Patients with histologic confirmation of primary metastatic or recurrent cervical cancer not amenable to surgical management were eligible. Treatment consisted of paclitaxel 175 mg/m2 IV and oxaliplatin 130 mg/m2 IV every 21 days. The primary endpoints were toxicity, recorded every cycle, and response, determined by RECIST criteria and were assessed every 9 weeks, with subsequent confirmation as required. Sample size determinations were made using a Simon's two-stage design with a projected overall response proportion of 13% with cisplatin alone. Survival rates were calculated with Kaplan-Meier methods. Results: Of the 35 patients enrolled, 32 were evaluable. The median age was 56 (27-78); 30 had had prior radiation (23 concomitant with cisplatin). Patients completed a mean of 4.2 cycles (1-11). There were 2 complete and 5 partial responses for a total response rate of 7/32 (22%; 95% CI: 9.3%-40.0%). Eight patients had stable disease for an overall clinical benefit rate of 15/32 (47%; 95% CI: 29.1%-65.3%). The mean time to best response was 13.5 weeks (95% CI: 10.6, 16.4). The mean progression-free survival was 21 weeks (95% CI: 14.7, 27.2) and mean overall survival was 52 weeks (95% CI: 39.4, 64.8). A total of 135 cycles were administered. There were 28 (20.1%) grade 3/4 hematologic toxicities and 46 (34.1%) grade 3/4 non-hematologic toxicities, which were predominantly sensory neuropathy. There were 13 treatment delays, 4 dose reductions, and no treatment-related deaths. Conclusions: The combination of paclitaxel and oxaliplatin is an effective regimen in patients with recurrent or persistent cervical cancer including a majority previously exposed to cisplatin. Further study and comparison with other platinum-based regimens is warranted.

AB - Objective: Survival in women with recurrent or metastatic cervical cancer remains poor. More effective and less toxic regimens are needed. Cisplatin is an effective radiosensitizer, but its single agent activity in recurrent cervical cancer, especially after prior cisplatin exposure, is disappointing, with a response rate of only 13%. Oxaliplatin has preclinical activity in cisplatin-resistant tumors and may have synergic activity when combined with paclitaxel. Our objective is to determine the efficacy and toxicity of paclitaxel and oxaliplatin in patients with recurrent or metastatic cervical cancer. Methods: Patients with histologic confirmation of primary metastatic or recurrent cervical cancer not amenable to surgical management were eligible. Treatment consisted of paclitaxel 175 mg/m2 IV and oxaliplatin 130 mg/m2 IV every 21 days. The primary endpoints were toxicity, recorded every cycle, and response, determined by RECIST criteria and were assessed every 9 weeks, with subsequent confirmation as required. Sample size determinations were made using a Simon's two-stage design with a projected overall response proportion of 13% with cisplatin alone. Survival rates were calculated with Kaplan-Meier methods. Results: Of the 35 patients enrolled, 32 were evaluable. The median age was 56 (27-78); 30 had had prior radiation (23 concomitant with cisplatin). Patients completed a mean of 4.2 cycles (1-11). There were 2 complete and 5 partial responses for a total response rate of 7/32 (22%; 95% CI: 9.3%-40.0%). Eight patients had stable disease for an overall clinical benefit rate of 15/32 (47%; 95% CI: 29.1%-65.3%). The mean time to best response was 13.5 weeks (95% CI: 10.6, 16.4). The mean progression-free survival was 21 weeks (95% CI: 14.7, 27.2) and mean overall survival was 52 weeks (95% CI: 39.4, 64.8). A total of 135 cycles were administered. There were 28 (20.1%) grade 3/4 hematologic toxicities and 46 (34.1%) grade 3/4 non-hematologic toxicities, which were predominantly sensory neuropathy. There were 13 treatment delays, 4 dose reductions, and no treatment-related deaths. Conclusions: The combination of paclitaxel and oxaliplatin is an effective regimen in patients with recurrent or persistent cervical cancer including a majority previously exposed to cisplatin. Further study and comparison with other platinum-based regimens is warranted.

KW - Oxaliplatin

KW - Paclitaxel

KW - Recurrent cervical cancer

KW - Response

KW - Toxicity

UR - http://www.scopus.com/inward/record.url?scp=75749123491&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=75749123491&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2009.10.082

DO - 10.1016/j.ygyno.2009.10.082

M3 - Article

C2 - 19931137

AN - SCOPUS:75749123491

VL - 116

SP - 442

EP - 446

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 3

ER -