Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study

John H. Edmonson; Vera J. Suman; Robert J. Dalton; Walter C. Bro; Mary M. Gallenberg; Harry J. Long; Ralph Levitt; Alan K. Hatfield; James E. Krook; James A. Mailliard; James B. Gerstner

doi:10.1081/CNV-100104287

Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study

John H. Edmonson, Vera J. Suman, Robert J. Dalton, Walter C. Bro, Mary M. Gallenberg, Harry J. Long, Ralph Levitt, Alan K. Hatfield, James E. Krook, James A. Mailliard, James B. Gerstner

Quantitative Health Sciences

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m² plus carboplatin 300 mg/m² vs. cyclophosphamide 600 mg/m² plus carboplatin 600 mg/m², each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 μg/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).

Original language	English (US)
Pages (from-to)	597-602
Number of pages	6
Journal	Cancer Investigation
Volume	19
Issue number	6
DOIs	https://doi.org/10.1081/CNV-100104287
State	Published - 2001

Keywords

Carboplatin
Cyclophosphamide
Dose intensity
GM-CSF (molgramostim)
Ovarian carcinoma

ASJC Scopus subject areas

Oncology
Cancer Research

Access to Document

10.1081/CNV-100104287

Cite this

Edmonson, J. H., Suman, V. J., Dalton, R. J., Bro, W. C., Gallenberg, M. M., Long, H. J., Levitt, R., Hatfield, A. K., Krook, J. E., Mailliard, J. A., & Gerstner, J. B. (2001). Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study. Cancer Investigation, 19(6), 597-602. https://doi.org/10.1081/CNV-100104287

Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study. / Edmonson, John H.; Suman, Vera J.; Dalton, Robert J. et al.
In: Cancer Investigation, Vol. 19, No. 6, 2001, p. 597-602.

Research output: Contribution to journal › Article › peer-review

Edmonson, JH, Suman, VJ, Dalton, RJ, Bro, WC, Gallenberg, MM, Long, HJ, Levitt, R, Hatfield, AK, Krook, JE, Mailliard, JA & Gerstner, JB 2001, 'Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study', Cancer Investigation, vol. 19, no. 6, pp. 597-602. https://doi.org/10.1081/CNV-100104287

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title = "Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study",

abstract = "Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m2 plus carboplatin 300 mg/m2 vs. cyclophosphamide 600 mg/m2 plus carboplatin 600 mg/m2, each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 μg/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).",

keywords = "Carboplatin, Cyclophosphamide, Dose intensity, GM-CSF (molgramostim), Ovarian carcinoma",

author = "Edmonson, {John H.} and Suman, {Vera J.} and Dalton, {Robert J.} and Bro, {Walter C.} and Gallenberg, {Mary M.} and Long, {Harry J.} and Ralph Levitt and Hatfield, {Alan K.} and Krook, {James E.} and Mailliard, {James A.} and Gerstner, {James B.}",

note = "Funding Information: This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic, and was supported in part by Public Health Service grants CA-15083, CA-25224, CA-37404, CA-37417, CA-35195, CA-35269, CA-63849, CA-35113, CA-52352, CA-35101, CA-35272, CA-35448, CA-35103, CA-35415, and CA-60276 from the National Cancer Institute Department of Health and Human Services. Additional participating institutions include: Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA (Martin Wiesenfeld, M.D.); Iowa Oncology Research Association CCOP, Des moines, IA (Roscoe F. Morton, M.D.); Altru Health Systems, Grand Forks, ND (Daniel J. Walsh, M.D.); Ochsner CCOP, New Orleans, LA (Carl G. Kardinal, M.D.); Geisinger Clinic & Medical Center CCOP, Danville, PA (Suresh Nair, M.D.); Saskatchewan Cancer Foundation to include Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada and Allan Blair Cancer Centre, Regina, Saskatchewn, Canada (Maria Tria Tirona, M.D.); Siouxland Hematology-Oncology Associates, Sioux City, IA (John C. Michalak, M.D.); Sioux Community Cancer Consortium, Sioux Falls, SD (Loren K. Tschetter, M.D.); CentraCare Clinic, St. Cloud, MN (Harold E. Windschitl, M.D.); Toledo Community Hospital Oncology Program CCOP, Toledo, OH (Paul L. Schaefer, M.D.); Quain and Ramstad Clinic, Bismarck, ND; Mid Dakota Clinic, Bismarck, ND (Ferdinand Addo, M.D.); Rapid City Regional Oncology Group, Rapid City, SD (Larry P. Ebbert, M.D.); and Scottsdale CCOP, Scottsdale, AZ (Richard Wheeler, M.D.).",

year = "2001",

doi = "10.1081/CNV-100104287",

language = "English (US)",

volume = "19",

pages = "597--602",

journal = "Cancer Investigation",

issn = "0735-7907",

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number = "6",

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TY - JOUR

T1 - Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma

T2 - A North Central Cancer Treatment Group study

AU - Edmonson, John H.

AU - Suman, Vera J.

AU - Dalton, Robert J.

AU - Bro, Walter C.

AU - Gallenberg, Mary M.

AU - Long, Harry J.

AU - Levitt, Ralph

AU - Hatfield, Alan K.

AU - Krook, James E.

AU - Mailliard, James A.

AU - Gerstner, James B.

N1 - Funding Information: This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic, and was supported in part by Public Health Service grants CA-15083, CA-25224, CA-37404, CA-37417, CA-35195, CA-35269, CA-63849, CA-35113, CA-52352, CA-35101, CA-35272, CA-35448, CA-35103, CA-35415, and CA-60276 from the National Cancer Institute Department of Health and Human Services. Additional participating institutions include: Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA (Martin Wiesenfeld, M.D.); Iowa Oncology Research Association CCOP, Des moines, IA (Roscoe F. Morton, M.D.); Altru Health Systems, Grand Forks, ND (Daniel J. Walsh, M.D.); Ochsner CCOP, New Orleans, LA (Carl G. Kardinal, M.D.); Geisinger Clinic & Medical Center CCOP, Danville, PA (Suresh Nair, M.D.); Saskatchewan Cancer Foundation to include Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada and Allan Blair Cancer Centre, Regina, Saskatchewn, Canada (Maria Tria Tirona, M.D.); Siouxland Hematology-Oncology Associates, Sioux City, IA (John C. Michalak, M.D.); Sioux Community Cancer Consortium, Sioux Falls, SD (Loren K. Tschetter, M.D.); CentraCare Clinic, St. Cloud, MN (Harold E. Windschitl, M.D.); Toledo Community Hospital Oncology Program CCOP, Toledo, OH (Paul L. Schaefer, M.D.); Quain and Ramstad Clinic, Bismarck, ND; Mid Dakota Clinic, Bismarck, ND (Ferdinand Addo, M.D.); Rapid City Regional Oncology Group, Rapid City, SD (Larry P. Ebbert, M.D.); and Scottsdale CCOP, Scottsdale, AZ (Richard Wheeler, M.D.).

PY - 2001

Y1 - 2001

N2 - Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m2 plus carboplatin 300 mg/m2 vs. cyclophosphamide 600 mg/m2 plus carboplatin 600 mg/m2, each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 μg/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).

AB - Between March 1992 and November 1994, 91 patients with stage III and IV ovarian carcinoma were enrolled in a randomized comparative study of cyclophosphamide 600 mg/m2 plus carboplatin 300 mg/m2 vs. cyclophosphamide 600 mg/m2 plus carboplatin 600 mg/m2, each regimen given monthly for six cycles. Patients on the intensive regimen also received 10 μg/kg of granulocyte macrophage colony stimulating factor (GM-CSF) (molgramostim) daily for 14 days following each chemotherapy treatment. The study was closed prematurely because of very poor case accrual following the preliminary announcement (in May 1993) that paclitaxel appeared superior to cyclophosphamide in the platinum-based treatment of ovarian cancer. More than 4 years after our last case entry, we analyzed the survival results for the 44 eligible patients who received the conventional dose of carboplatin and the 43 eligible patients receiving our intensified dose of carboplatin. More than 90% of the treated patients receiving the conventional dose regimen received at least 75% of the planned doses at each of the six treatment intervals, whereas the percentage of treated patients able to receive at least 75% of the assigned intensive dose regimen had declined from 95% in cycle 2 to 53% by cycle 6. Furthermore, although 32 patients received all six planned cycles of treatment in the conventional regimen group, only 15 received all six cycles of the intensified regimen. Patients receiving the intensive regimen had more fever, dermatitis, lethargy, musculoskeletal pain, and pulmonary complications than did the conventional dose patients. Median survival times for the two treatment groups were very similar (38.5 and 38.1 months, respectively, for the conventional and intensive regimens), and we saw no evidence that the distribution of survival times differed between the treatment regimens (p = 0.95).

KW - Carboplatin

KW - Cyclophosphamide

KW - Dose intensity

KW - GM-CSF (molgramostim)

KW - Ovarian carcinoma

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Comparison of conventional dose and double dose carboplatin in patients receiving cyclophosphamide plus carboplatin for advanced ovarian carcinoma: A North Central Cancer Treatment Group study

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