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

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
  1. Biopsy-proven invasive squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix.
  2. FIGO stage IIB, III, or IVA
  3. Normal renal, hepatic, and bone marrow function
  4. Free of clinically significant infection
  5. No prior exposure to pelvic irradiation or cytotoxic chemotherapy.
  6. No medical contraindications to surgery
  7. GOG performance grade of 3 or lower
Exclusion criteria
  1. History of other cancers, other than skin cancer but excluding melanoma
  2. 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

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