13-cis-retinoic acid or All-trans-retinoic acid plus interferon-α in recurrent cervical cancer: A Southwest Oncology Group phase II randomized trial

Geoffrey R. Weiss, P. Y. Liu, David S. Alberts, Yei Mei Peng, Emily Fisher, Min Jian Xu, Sidney A Scudder, Laurence H. Baker, Dennis F. Moore, Scott M. Lippman

Research output: Contribution to journalArticle

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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 languageEnglish (US)
Pages (from-to)386-390
Number of pages5
JournalGynecologic Oncology
Volume71
Issue number3
DOIs
StatePublished - Dec 1998

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Isotretinoin
Tretinoin
Uterine Cervical Neoplasms
Interferons
Retinoids
Cervix Uteri
Squamous Cell Carcinoma
Radiotherapy
Confidence Intervals
Adenosquamous Carcinoma
Subcutaneous Injections
Random Allocation
Fatigue
Radiation

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 journalArticle

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. / 13-cis-retinoic acid or All-trans-retinoic acid plus interferon-α in recurrent cervical cancer : A Southwest Oncology Group phase II randomized trial. In: Gynecologic Oncology. 1998 ; Vol. 71, No. 3. pp. 386-390.
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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.",
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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

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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.

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