GOG 85 Study
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
Disease site
Cervix
Pubmed link
Publication month/year
May 1999
Study question
Determine the superior chemoradiation regimen between Fluorouracil plus Cisplatin versus Hydroxyurea as an adjunct to radiation for the treatment of stage IIB/IVA carcinoma of the cervix
Type of study
Randomised controlled trial (RCT)
Interventions compared
Radiation+Fluorouracil+Cisplatin vs Radiation+Hydroxyurea
Experimental arm (Intervention)
Radiotherapy with concurrent 5-FU infusion and bolus CF
Control arm
Radiotherapy and oral HU.
Primary outcome
- Overall survival (OS)
- Progression-Free Interval
Secondary outcome
- Disease Progression
- Site of Progression
Inclusion criteria
- Biopsy-proven invasive squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix.
- FIGO stage IIB, III, or IVA
- Normal renal, hepatic, and bone marrow function
- Free of clinically significant infection
- No prior exposure to pelvic irradiation or cytotoxic chemotherapy.
- No medical contraindications to surgery
- GOG performance grade of 3 or lower
Exclusion criteria
- History of other cancers, other than skin cancer but excluding melanoma
- Metastasis to the para-aortic lymph nodes or intra- abdominal structures or positive cytologic washings.
Results
| RT + 5-FU + CF | RT + HU | |
|---|---|---|
|
Randomised (n) |
188 |
200 |
|
Received treatment |
177 |
191 |
|
Death (n) |
79 |
108 |
|
Disease progression (n) |
76 |
101 |
Other Results
PFS was statistically significant favoring the CF regimen
The RR of progression/death of the CF group to the HU group was 0.79
Conclusions
- Patients can expect an increase in survival when radiation is combined with 5-FU and CF
- 26% reduction in the risk of death (RR, 0.74) for patients with locally advanced cervical carcinoma treated with 5-FU and CF concomitant with pelvic radiation therapy
Study limitations
- Radiotherapy failure may be due to the unrecognized metastatic disease at diagnosis
- Radiotherapy failure rate for patients with stage IIB disease is 20% to 50%; for patients with more extensive stage III disease, the failure rate ranges from 50% to as high as 75%.
Reviewer name
Laith Shlash