Concurrent Chemotherapy and Pelvic Radiation Therapy Compared with Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix.

Disease site

Cervix

Publication month/year

February, 2000

Study question

To evaluate if the addition of Cisplatin (with or without fluorouracil) chemotherapy to standard pelvic radiation therapy could improve the progression-free survival and overall survival of patients at high risk for relapse after primary radical hysterectomy

Type of study

Randomised controlled trial (RCT)

Interventions compared

Addition of chemotherapy vs Standard therapy alone

Experimental arm (Intervention)

Chemotherapy, in addition to standard therapy (Radiotherapy)

Control arm

Standard therapy (Radiotherapy) devoid of chemotherapy

Primary outcome
  • Progression-free survival 
  • Overall survival
Secondary outcome
  • Toxicity in the experimental arm
Inclusion criteria
  • Patients undergoing a type 3 hysterectomy with pelvic lymphadenectomy for carcinoma of the cervix.
  • Stage of carcinoma 
    • IA2, IB, or IIA
  • Patients having squamous carcinoma, adenocarcinoma or an adenosquamous carcinoma with histologically confirmed positive pelvic lymph nodes, positive parametrial involvement or positive surgical margin.
Exclusion criteria

Nil

Results
Intervention arm Control arm
Randomised(n) 127 116
Received treatment Chemotherapy + Radiotherapy Radiotherapy Alone
Median follow-up period 42 months 42 months
Estimated 4-year progression free survival 80% 63%
Overall 4-year survival 81% 71%
Toxicity (Grade 4) 21 (17.2%) 4 (3.5%)
Pelvic and extra pelvic recurrences 40 78
Other results

Higher numbers of chemotherapy courses are favourably associated with both progression-free survival and overall survival.

Conclusions
  • Patients receiving both chemotherapy and radiation therapy had a statistically significant improvement in progression free survival, overall survival and decreased recurrence rates
  • Patients receiving both chemotherapy and radiation therapy display a greater degree of toxicity, which must be considered into treatment decision
Study limitations
  • Could not assess if the effect of chemotherapy is independent of radiotherapy due to inherit characteristics of the studied sample (i.e poor tolerance to chemotherapy)
  • The statistical boundaries for rejecting the study’s null hypothesis were crossed out
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