Abstract
Purpose. Preclinical and clinical data support the study of retinoids and interferon-α (IFN-α) in advanced squamous cell carcinoma of the uterine cervix (SCC). This phase II randomized trial of the Southwest Oncology Group sought to estimate the response rate for IFN-α plus either 13-c/s-retinoic acid (13cRA) or all-trans-retinoic acid (ATRA) in women with recurrent cervical SCC. Patients and Methods. Eligibility for this trial required bidimensionally measurable locally recurrent or metastatic squamous or adenosquamous carcinoma of the uterine cervix; SWOG performance status of ≤2; no prior interferon, retinoids, or chemotherapy (except as radiation sensitization). All but two patients were previously treated with surgery, radiation therapy, or both. After randomization, patients received IFN-α-2A (subcutaneous injection; 3 x 106 units/m2/day) plus either 13cRA (1 mg/kg/day orally) or ATRA (150 mg/m2/day orally) in two equally divided doses. Results. Total enrollment was 63 patients, 21 in the ATRA arm, 42 in the 13cRA arm. Three patients were ineligible, 1 in the ATRA arm, 2 in the 13cRA arm. Each arm had 1 patient who received no assigned treatment and was not evaluated for response or toxicity. The ATRA/IFN-α response rate was 5% (1/19; 95% confidence interval = 0.1-26%), consisting of 1 partial response lasting 4 weeks. The 13cRA/IFN-α response rate was 8% (3/39; 95% confidence interval = 2-21%), consisting of 3 partial responses lasting 17, 22, and 24 weeks, respectively. All confirmed responses were partial. One additional unconfirmed partial response occurred in the 13cRA arm. Both regimens were generally well-tolerated and produced toxicities (principally malaise and fatigue) associated with each constituent agent's known single-agent side effects. Conclusion. Based upon the results of this study, neither regimen can be recommended for further study in patients previously treated with radiation therapy.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 386-390 |
| Number of pages | 5 |
| Journal | Gynecologic Oncology |
| Volume | 71 |
| Issue number | 3 |
| DOIs | |
| State | Published - Dec 1998 |
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ASJC Scopus subject areas
- Obstetrics and Gynecology
- Oncology
Cite this
13-cis-retinoic acid or All-trans-retinoic acid plus interferon-α in recurrent cervical cancer : A Southwest Oncology Group phase II randomized trial. / Weiss, Geoffrey R.; Liu, P. Y.; Alberts, David S.; Peng, Yei Mei; Fisher, Emily; Xu, Min Jian; Scudder, Sidney A; Baker, Laurence H.; Moore, Dennis F.; Lippman, Scott M.
In: Gynecologic Oncology, Vol. 71, No. 3, 12.1998, p. 386-390.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - 13-cis-retinoic acid or All-trans-retinoic acid plus interferon-α in recurrent cervical cancer
T2 - A Southwest Oncology Group phase II randomized trial
AU - Weiss, Geoffrey R.
AU - Liu, P. Y.
AU - Alberts, David S.
AU - Peng, Yei Mei
AU - Fisher, Emily
AU - Xu, Min Jian
AU - Scudder, Sidney A
AU - Baker, Laurence H.
AU - Moore, Dennis F.
AU - Lippman, Scott M.
PY - 1998/12
Y1 - 1998/12
N2 - Purpose. Preclinical and clinical data support the study of retinoids and interferon-α (IFN-α) in advanced squamous cell carcinoma of the uterine cervix (SCC). This phase II randomized trial of the Southwest Oncology Group sought to estimate the response rate for IFN-α plus either 13-c/s-retinoic acid (13cRA) or all-trans-retinoic acid (ATRA) in women with recurrent cervical SCC. Patients and Methods. Eligibility for this trial required bidimensionally measurable locally recurrent or metastatic squamous or adenosquamous carcinoma of the uterine cervix; SWOG performance status of ≤2; no prior interferon, retinoids, or chemotherapy (except as radiation sensitization). All but two patients were previously treated with surgery, radiation therapy, or both. After randomization, patients received IFN-α-2A (subcutaneous injection; 3 x 106 units/m2/day) plus either 13cRA (1 mg/kg/day orally) or ATRA (150 mg/m2/day orally) in two equally divided doses. Results. Total enrollment was 63 patients, 21 in the ATRA arm, 42 in the 13cRA arm. Three patients were ineligible, 1 in the ATRA arm, 2 in the 13cRA arm. Each arm had 1 patient who received no assigned treatment and was not evaluated for response or toxicity. The ATRA/IFN-α response rate was 5% (1/19; 95% confidence interval = 0.1-26%), consisting of 1 partial response lasting 4 weeks. The 13cRA/IFN-α response rate was 8% (3/39; 95% confidence interval = 2-21%), consisting of 3 partial responses lasting 17, 22, and 24 weeks, respectively. All confirmed responses were partial. One additional unconfirmed partial response occurred in the 13cRA arm. Both regimens were generally well-tolerated and produced toxicities (principally malaise and fatigue) associated with each constituent agent's known single-agent side effects. Conclusion. Based upon the results of this study, neither regimen can be recommended for further study in patients previously treated with radiation therapy.
AB - Purpose. Preclinical and clinical data support the study of retinoids and interferon-α (IFN-α) in advanced squamous cell carcinoma of the uterine cervix (SCC). This phase II randomized trial of the Southwest Oncology Group sought to estimate the response rate for IFN-α plus either 13-c/s-retinoic acid (13cRA) or all-trans-retinoic acid (ATRA) in women with recurrent cervical SCC. Patients and Methods. Eligibility for this trial required bidimensionally measurable locally recurrent or metastatic squamous or adenosquamous carcinoma of the uterine cervix; SWOG performance status of ≤2; no prior interferon, retinoids, or chemotherapy (except as radiation sensitization). All but two patients were previously treated with surgery, radiation therapy, or both. After randomization, patients received IFN-α-2A (subcutaneous injection; 3 x 106 units/m2/day) plus either 13cRA (1 mg/kg/day orally) or ATRA (150 mg/m2/day orally) in two equally divided doses. Results. Total enrollment was 63 patients, 21 in the ATRA arm, 42 in the 13cRA arm. Three patients were ineligible, 1 in the ATRA arm, 2 in the 13cRA arm. Each arm had 1 patient who received no assigned treatment and was not evaluated for response or toxicity. The ATRA/IFN-α response rate was 5% (1/19; 95% confidence interval = 0.1-26%), consisting of 1 partial response lasting 4 weeks. The 13cRA/IFN-α response rate was 8% (3/39; 95% confidence interval = 2-21%), consisting of 3 partial responses lasting 17, 22, and 24 weeks, respectively. All confirmed responses were partial. One additional unconfirmed partial response occurred in the 13cRA arm. Both regimens were generally well-tolerated and produced toxicities (principally malaise and fatigue) associated with each constituent agent's known single-agent side effects. Conclusion. Based upon the results of this study, neither regimen can be recommended for further study in patients previously treated with radiation therapy.
UR - http://www.scopus.com/inward/record.url?scp=0032408337&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032408337&partnerID=8YFLogxK
U2 - 10.1006/gyno.1998.5204
DO - 10.1006/gyno.1998.5204
M3 - Article
C2 - 9887236
AN - SCOPUS:0032408337
VL - 71
SP - 386
EP - 390
JO - Gynecologic Oncology
JF - Gynecologic Oncology
SN - 0090-8258
IS - 3
ER -