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Long-Term Disease Control with Triapine-Based Radiochemotherapy for Patients with Stage IB2-IIIB Cervical Cancer.

Kunos CA, Sherertz TM - Front Oncol (2014)

Bottom Line: The Kaplan-Meier method estimated survivals.A median 3.4 years of follow-up time (range, 0.3-7.6 years) has been observed.The 3-year pelvic locoregional relapse rate, disease-free survival, and overall survival were 4% [95% confidence interval (CI), 0-20%], 80% (95% CI: 71-89%), and 82% (95% CI: 74-90%), respectively.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, Summa Cancer Institute, Summa Health System , Akron, OH , USA.

ABSTRACT

Background: National Cancer Institute phase I #7336 and phase II #8327 clinical trials explored the safety and efficacy of triapine (NSC #663249) added to cisplatin radiochemotherapy in untreated patients with advanced-stage cervical cancer. Triapine inhibits ribonucleotide reductase, the rate-limiting enzyme responsible for DNA-building deoxyribonucleotides, and thereby, enhances radiochemosensitivity by prolonging DNA repair time. Here, we report 3-year efficacy endpoints of pelvic locoregional relapse rate, disease-free, and overall survivals.

Methods: Eligible patients with bulky IB-IIIB cervical cancer underwent three-times weekly triapine (25 or 50 mg/m(2)), once-weekly cisplatin (40 mg/m(2)), and conventional daily pelvic radiation followed by brachytherapy. A cumulative incidence method estimated pelvic locoregional relapse rates. Disease-free survival was measured from radiochemotherapy start date to the date of first relapse or cancer-related death. Overall survival was measured from radiochemotherapy start date to the date of any-cause death. The Kaplan-Meier method estimated survivals.

Findings: Between 2006 and 2011, 24 untreated patients with cervical cancer met criteria for reporting in this study. A median 3.4 years of follow-up time (range, 0.3-7.6 years) has been observed. All had squamous cancers and the majority had either node-positive stage IB-IIA (33%) or stage IIIB (42%) disease. The 3-year pelvic locoregional relapse rate, disease-free survival, and overall survival were 4% [95% confidence interval (CI), 0-20%], 80% (95% CI: 71-89%), and 82% (95% CI: 74-90%), respectively.

Interpretation: Triapine radiochemotherapy was safe, active, and effective in patients with untreated advanced-stage cervical cancer, worthy of randomized clinical trial study.

No MeSH data available.


Related in: MedlinePlus

STROBE diagram for progress through stages of analysis. STROBE, strengthening the reporting of observational studies in epidemiology.
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Figure 1: STROBE diagram for progress through stages of analysis. STROBE, strengthening the reporting of observational studies in epidemiology.

Mentions: For the triapine dose-finding phase I protocol #7336, eligible patients had any histologically confirmed primary or recurrent pelvic gynecologic malignancy not amenable to curative surgery. For the triapine efficacy phase II protocol #8327, eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma staged IB2–IVB of the uterine cervix or staged II–IV of the vagina. Prior reports list detailed eligibility criteria (1, 2). Herein, we exclusively report on those enrolled patients with International Federation of Gynecologists and Obstetricians (FIGO) stage II or IIIB disease, or node-positive FIGO stage IB2 whose tumor size exceeded 5 cm (Figure 1; Table 1). All patients provided written informed consent. University Hospitals of Cleveland and Case Western Reserve University (Cleveland, OH, USA) institutional review board approvals were granted for these clinical trials. The Case Comprehensive Cancer Center of University Hospitals of Cleveland and Case Western Reserve University provided oversight for the data and safety monitoring plans.


Long-Term Disease Control with Triapine-Based Radiochemotherapy for Patients with Stage IB2-IIIB Cervical Cancer.

Kunos CA, Sherertz TM - Front Oncol (2014)

STROBE diagram for progress through stages of analysis. STROBE, strengthening the reporting of observational studies in epidemiology.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4109518&req=5

Figure 1: STROBE diagram for progress through stages of analysis. STROBE, strengthening the reporting of observational studies in epidemiology.
Mentions: For the triapine dose-finding phase I protocol #7336, eligible patients had any histologically confirmed primary or recurrent pelvic gynecologic malignancy not amenable to curative surgery. For the triapine efficacy phase II protocol #8327, eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma staged IB2–IVB of the uterine cervix or staged II–IV of the vagina. Prior reports list detailed eligibility criteria (1, 2). Herein, we exclusively report on those enrolled patients with International Federation of Gynecologists and Obstetricians (FIGO) stage II or IIIB disease, or node-positive FIGO stage IB2 whose tumor size exceeded 5 cm (Figure 1; Table 1). All patients provided written informed consent. University Hospitals of Cleveland and Case Western Reserve University (Cleveland, OH, USA) institutional review board approvals were granted for these clinical trials. The Case Comprehensive Cancer Center of University Hospitals of Cleveland and Case Western Reserve University provided oversight for the data and safety monitoring plans.

Bottom Line: The Kaplan-Meier method estimated survivals.A median 3.4 years of follow-up time (range, 0.3-7.6 years) has been observed.The 3-year pelvic locoregional relapse rate, disease-free survival, and overall survival were 4% [95% confidence interval (CI), 0-20%], 80% (95% CI: 71-89%), and 82% (95% CI: 74-90%), respectively.

View Article: PubMed Central - PubMed

Affiliation: Department of Radiation Oncology, Summa Cancer Institute, Summa Health System , Akron, OH , USA.

ABSTRACT

Background: National Cancer Institute phase I #7336 and phase II #8327 clinical trials explored the safety and efficacy of triapine (NSC #663249) added to cisplatin radiochemotherapy in untreated patients with advanced-stage cervical cancer. Triapine inhibits ribonucleotide reductase, the rate-limiting enzyme responsible for DNA-building deoxyribonucleotides, and thereby, enhances radiochemosensitivity by prolonging DNA repair time. Here, we report 3-year efficacy endpoints of pelvic locoregional relapse rate, disease-free, and overall survivals.

Methods: Eligible patients with bulky IB-IIIB cervical cancer underwent three-times weekly triapine (25 or 50 mg/m(2)), once-weekly cisplatin (40 mg/m(2)), and conventional daily pelvic radiation followed by brachytherapy. A cumulative incidence method estimated pelvic locoregional relapse rates. Disease-free survival was measured from radiochemotherapy start date to the date of first relapse or cancer-related death. Overall survival was measured from radiochemotherapy start date to the date of any-cause death. The Kaplan-Meier method estimated survivals.

Findings: Between 2006 and 2011, 24 untreated patients with cervical cancer met criteria for reporting in this study. A median 3.4 years of follow-up time (range, 0.3-7.6 years) has been observed. All had squamous cancers and the majority had either node-positive stage IB-IIA (33%) or stage IIIB (42%) disease. The 3-year pelvic locoregional relapse rate, disease-free survival, and overall survival were 4% [95% confidence interval (CI), 0-20%], 80% (95% CI: 71-89%), and 82% (95% CI: 74-90%), respectively.

Interpretation: Triapine radiochemotherapy was safe, active, and effective in patients with untreated advanced-stage cervical cancer, worthy of randomized clinical trial study.

No MeSH data available.


Related in: MedlinePlus