Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study

David S Alberts, John A. Blessing, Lisa M. Landrum, David P. Warshal, Lainie P. Martin, Stephen L. Rose, Albert J. Bonebrake, Lois M. Ramondetta

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background: Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied > 20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer. Methods: Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m2 IV over 30 minutes on days 1, 8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed. Results: Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1-15). Ten (28.6%; CI 14.6%-46.3%) of the 35 patients had a partial response and another 15 patients (42.9%) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7%) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9%) patient and resolved to grade 2 following dose discontinuation. Conclusions: Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer.

Original languageEnglish (US)
Pages (from-to)451-455
Number of pages5
JournalGynecologic Oncology
Volume127
Issue number3
DOIs
StatePublished - Dec 2012

Fingerprint

Uterine Cervical Neoplasms
Nanoparticles
Therapeutics
Pharmaceutical Preparations
Drug Therapy
Albumin-Bound Paclitaxel
Drug Combinations
Neutropenia
Platinum
Cisplatin
Disease-Free Survival
Radiotherapy

Keywords

  • Cervix cancer
  • Drug resistant cervix cancer
  • GOG
  • Nab-paclitaxel

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer : A gynecologic oncology group study. / Alberts, David S; Blessing, John A.; Landrum, Lisa M.; Warshal, David P.; Martin, Lainie P.; Rose, Stephen L.; Bonebrake, Albert J.; Ramondetta, Lois M.

In: Gynecologic Oncology, Vol. 127, No. 3, 12.2012, p. 451-455.

Research output: Contribution to journalArticle

Alberts, David S ; Blessing, John A. ; Landrum, Lisa M. ; Warshal, David P. ; Martin, Lainie P. ; Rose, Stephen L. ; Bonebrake, Albert J. ; Ramondetta, Lois M. / Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer : A gynecologic oncology group study. In: Gynecologic Oncology. 2012 ; Vol. 127, No. 3. pp. 451-455.
@article{6e7e02ec3bbe48c5bdf0fe18c45b03c0,
title = "Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study",
abstract = "Background: Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied > 20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer. Methods: Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m2 IV over 30 minutes on days 1, 8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed. Results: Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1-15). Ten (28.6{\%}; CI 14.6{\%}-46.3{\%}) of the 35 patients had a partial response and another 15 patients (42.9{\%}) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7{\%}) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9{\%}) patient and resolved to grade 2 following dose discontinuation. Conclusions: Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer.",
keywords = "Cervix cancer, Drug resistant cervix cancer, GOG, Nab-paclitaxel",
author = "Alberts, {David S} and Blessing, {John A.} and Landrum, {Lisa M.} and Warshal, {David P.} and Martin, {Lainie P.} and Rose, {Stephen L.} and Bonebrake, {Albert J.} and Ramondetta, {Lois M.}",
year = "2012",
month = "12",
doi = "10.1016/j.ygyno.2012.09.008",
language = "English (US)",
volume = "127",
pages = "451--455",
journal = "Gynecologic Oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",

}

TY - JOUR

T1 - Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer

T2 - A gynecologic oncology group study

AU - Alberts, David S

AU - Blessing, John A.

AU - Landrum, Lisa M.

AU - Warshal, David P.

AU - Martin, Lainie P.

AU - Rose, Stephen L.

AU - Bonebrake, Albert J.

AU - Ramondetta, Lois M.

PY - 2012/12

Y1 - 2012/12

N2 - Background: Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied > 20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer. Methods: Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m2 IV over 30 minutes on days 1, 8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed. Results: Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1-15). Ten (28.6%; CI 14.6%-46.3%) of the 35 patients had a partial response and another 15 patients (42.9%) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7%) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9%) patient and resolved to grade 2 following dose discontinuation. Conclusions: Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer.

AB - Background: Metastatic and recurrent, platinum resistant cervix cancer has an extremely poor prognosis. The Gynecologic Oncology Group has studied > 20 cytotoxic drugs or drug combinations in the second-line, phase II setting of advanced, drug resistant cervix cancer. Methods: Nanoparticle, albumin-bound paclitaxel (nab-paclitaxel) was administered at 125 mg/m2 IV over 30 minutes on days 1, 8 and 15 of each 28 day cycle to 37 women with metastatic or recurrent cervix cancer that had progressed or relapsed following first-line cytotoxic drug treatment. A flexible, 2-stage accrual design that allowed stopping early for lack of treatment activity was utilized. Because of slow patient accrual, the second stage was not completed. Results: Of 37 patients enrolled, 2 were ineligible due to no prior cytotoxic chemotherapy, which left 35 eligible patients evaluable for response and tolerability. All of the eligible patients had 1 prior chemotherapy regimen and 27 of them had prior radiation therapy with concomitant cisplatin. The median number of nab-paclitaxel cycles were 4 (range 1-15). Ten (28.6%; CI 14.6%-46.3%) of the 35 patients had a partial response and another 15 patients (42.9%) had stable disease. The median progression-free and overall survival were 5.0 and 9.4 months, respectively. The only NCI CTCAE grade 4 event was neutropenia in 2 patients (5.7%) which resolved following dose reduction. Grade 3 neurotoxicity was reported in 1 (2.9%) patient and resolved to grade 2 following dose discontinuation. Conclusions: Nab-paclitaxel has considerable activity and moderate toxicity in the treatment of drug resistant, metastatic and recurrent cervix cancer.

KW - Cervix cancer

KW - Drug resistant cervix cancer

KW - GOG

KW - Nab-paclitaxel

UR - http://www.scopus.com/inward/record.url?scp=84868597108&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84868597108&partnerID=8YFLogxK

U2 - 10.1016/j.ygyno.2012.09.008

DO - 10.1016/j.ygyno.2012.09.008

M3 - Article

C2 - 22986144

AN - SCOPUS:84868597108

VL - 127

SP - 451

EP - 455

JO - Gynecologic Oncology

JF - Gynecologic Oncology

SN - 0090-8258

IS - 3

ER -