Journal of Clinical Oncology, Vol 3, 1079-1085, Copyright © 1985 by American Society of Clinical Oncology
Randomized trial of three cisplatin dose schedules in squamous-cell carcinoma of the cervix: a Gynecologic Oncology Group study
P Bonomi, JA Blessing, FB Stehman, PJ DiSaia, L Walton and FJ Major
The Gynecologic Oncology Group has conducted a randomized prospective trial
comparing cisplatin 50 mg/m2 every 21 days (regimen 1), 100 mg/m2 every 21
days (regimen 2), and cisplatin 20 mg/m2 for five consecutive days repeated
every 21 days (regimen 3). Four hundred ninety-seven evaluable patients
have been accrued on this study. The response rates were 20.7%, 31.4%, and
25.0%, for regimens 1, 2, and 3, respectively; the complete remission rates
were 10.0%, 12.7%, and 8.6% for regimens 1, 2, and 3, respectively. The
median duration of response ranged from 3.9 to 4.8 months, the median
progression-free interval from 3.7 to 4.6 months, and the median survival
time from 6.1 to 7.1 months. The difference in response rates for regimens
1 and 2 is statistically significant (P = .015) but less than the magnitude
originally considered clinically significant. The differences in complete
remission rates, response duration, progression-free interval, and survival
times are not statistically significant. The following types of toxicity
were observed: serum creatinine level greater than 2 mg/dL and/or BUN level
greater than 40 mg/dL was 7%, 14%, and 17% on regimens 1, 2, and 3,
respectively; leukocyte count less than 4,000/microL was 27%, 44%, and 41%
on regimens 1, 2, and 3, respectively. Nausea and vomiting occurred in 74
patients (83%). The regimen consisting of a 100- mg/m2 single dose has
produced a statistically significant higher response rate than the 50 mg/m2
regimen while producing no appreciable differences in complete remission
rate, response duration, progression- free interval, or survival. In
addition, the higher dose regimen was associated with greater
myelosuppression and nephrotoxicity.
 CiteULike  Complore  Connotea  Del.icio.us  Digg  Facebook  Reddit  Technorati  Twitter What's this?
This article has been cited by other articles:
|
|
|
|
 
G. Mountzios, M. A. Dimopoulos, A. Bamias, G. Vourli, H. Kalofonos, G. Aravantinos, G. Fountzilas, and C. A. Papadimitriou
Randomized multicenter phase II trial of cisplatin and ifosfamide with or without paclitaxel in recurrent or metastatic carcinoma of the uterine cervix: a Hellenic Cooperative Oncology Group (HeCOG) study
Ann. Onc.,
May 20, 2009;
(2009)
mdn797v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. J. Long III, N. N. I. Laack, and B. S. Gostout
Prevention, Diagnosis, and Treatment of Cervical Cancer
Mayo Clin. Proc.,
December 1, 2007;
82(12):
1566 - 1574.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. J. Long III
Management of Metastatic Cervical Cancer: Review of the Literature
J. Clin. Oncol.,
July 10, 2007;
25(20):
2966 - 2974.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. J. Long III, B. N. Bundy, E. C. Grendys Jr, J. A. Benda, D. S. McMeekin, J. Sorosky, D. S. Miller, L. A. Eaton, and J. V. Fiorica
Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
July 20, 2005;
23(21):
4626 - 4633.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Buda, R. Fossati, N. Colombo, F. Fei, I. Floriani, D. Gueli Alletti, D. Katsaros, F. Landoni, A. Lissoni, C. Malzoni, et al.
Randomized Trial of Neoadjuvant Chemotherapy Comparing Paclitaxel, Ifosfamide, and Cisplatin With Ifosfamide and Cisplatin Followed by Radical Surgery in Patients With Locally Advanced Squamous Cell Cervical Carcinoma: The SNAP01 (Studio Neo-Adjuvante Portio) Italian Collaborative Study
J. Clin. Oncol.,
June 20, 2005;
23(18):
4137 - 4145.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Morris, J. A. Blessing, B. J. Monk, R. McGehee, and D. H. Moore
Phase II Study of Cisplatin and Vinorelbine in Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
August 15, 2004;
22(16):
3340 - 3344.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. H. Moore, J. A. Blessing, R. P. McQuellon, H. T. Thaler, D. Cella, J. Benda, D. S. Miller, G. Olt, S. King, J. F. Boggess, et al.
Phase III Study of Cisplatin With or Without Paclitaxel in Stage IVB, Recurrent, or Persistent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
August 1, 2004;
22(15):
3113 - 3119.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M Garipagaoglu, F Kayikcioglu, M F Kose, M Adli, K H Gulkesen, Z Kocak, and G Tulunay
Adding concurrent low dose continuous infusion of cisplatin to radiotherapy in locally advanced cervical carcinoma: a prospective randomized pilot study
Br. J. Radiol.,
July 1, 2004;
77(919):
581 - 587.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. V. Fiorica
Update on the Treatment of Cervical and Uterine Carcinoma: Focus on Topotecan
Oncologist,
October 1, 2002;
7(90005):
36 - 45.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Friedlander and M. Grogan
Guidelines for the Treatment of Recurrent and Metastatic Cervical Cancer
Oncologist,
August 1, 2002;
7(4):
342 - 347.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T.-C. Chang, C.-H. Lai, J.-H. Hong, S. Hsueh, K.-G. Huang, H.-H. Chou, C.-J. Tseng, C.-S. Tsai, J. T. Chang, C.-T. Lin, et al.
Randomized Trial of Neoadjuvant Cisplatin, Vincristine, Bleomycin, and Radical Hysterectomy Versus Radiation Therapy for Bulky Stage IB and IIA Cervical Cancer
J. Clin. Oncol.,
April 1, 2000;
18(8):
1740 - 1747.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
P. G. Rose, J. A. Blessing, D. M. Gershenson, and R. McGehee
Paclitaxel and Cisplatin as First-Line Therapy in Recurrent or Advanced Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study
J. Clin. Oncol.,
September 1, 1999;
17(9):
2676 - 2676.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. W. Whitney, W. Sause, B. N. Bundy, J. H. Malfetano, E. V. Hannigan, W. C. Fowler Jr, D. L. Clarke-Pearson, and S.-Y. Liao
Randomized Comparison of Fluorouracil Plus Cisplatin Versus Hydroxyurea as an Adjunct to Radiation Therapy in Stage IIB-IVA Carcinoma of the Cervix With Negative Para-Aortic Lymph Nodes: A Gynecologic Oncology Group and Southwest Oncology Group Study
J. Clin. Oncol.,
May 1, 1999;
17(5):
1339 - 1339.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
H. M. Keys, B. N. Bundy, F. B. Stehman, L. I. Muderspach, W. E. Chafe, C. L. Suggs, J. L. Walker, and D. Gersell
Cisplatin, Radiation, and Adjuvant Hysterectomy Compared with Radiation and Adjuvant Hysterectomy for Bulky Stage IB Cervical Carcinoma
N. Engl. J. Med.,
April 15, 1999;
340(15):
1154 - 1161.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. Pignata, G. Silvestro, E. Ferrari, L. Selvaggi, F. Perrone, A. Maffeo, P. Frezza, G. Di Vagno, G. Casella, P. Ricchi, et al.
Phase II Study of Cisplatin and Vinorelbine as First-Line Chemotherapy in Patients With Carcinoma of the Uterine Cervix
J. Clin. Oncol.,
March 1, 1999;
17(3):
756 - 756.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. A. Cannistra and J. M. Niloff
Cancer of the Uterine Cervix
N. Engl. J. Med.,
April 18, 1996;
334(16):
1030 - 1037.
[Full Text]
[PDF]
|
|
|
|
