Cisplatin, radiation and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma

Disease site

Cervix

Publication month/year

April / 1999

Study question

To determine whether concurrent weekly treatment with cisplatin during radiotherapy would improve progression-free survival and survival in women with large “bulky,” or barrel-shaped, stage IB cervical cancers.

Type of study

Phase 3 trial study

Interventions compared

Cisplatin infusions / No Cisplatin infusions with radiation and adjuvant hysterectomy in stage IB cervical carcinoma

Experimental arm (Intervention)

Cisplatin infusions with radiation and adjuvant hysterectomy in stage IB cervical carcinoma

Control arm

No Cisplatin infusions with radiation and adjuvant hysterectomy in stage IB cervical carcinoma

Primary outcome

Improve progression-free survival and survival

Inclusion criteria
  • Women of any age with biopsy-proved primary squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix of stage IB (exophytic or expansile barrel-shaped tumors with a minimum diameter of 4 cm).
  • Gynecologic Oncology Group performance status of 0, 1, 2, or 3.
  • Adequate bone marrow, renal function, and hepatic function.
  • To be medically suitable for hysterectomy.
Exclusion criteria

Patients with radiographic evidence of lymphadenopathy on computed tomographic scanning or lymphangiography, and in those with enlarged or suspicious-appearing lymph nodes, no evidence of cancer on fine-needle aspiration or histologic evaluation. 

Results:
The risk of recurrence and death was significantly reduced by concurrent treatment with cisplatin and radiotherapy.
Intervention arm (cisplatin) Control arm (no_cisplatin)
Randomised(n0) 183 / 369 186 / 369
Received treatment Cisplatin (besides radiation and hysterectomy) Only radiation and hysterectomy
Outcome 1 (survival rate) Improvement in survival rates (P=0.008) No change in survival rates
Outcome 2 (recurrence rate) Reduction in recurrence rates No change in recurrence rates
Conclusions

Adding weekly infusions of cisplatin to pelvic radiotherapy followed by hysterectomy significantly reduced the risk of disease recurrence and death in women with bulky stage IB cervical cancers.

Study limitations

The possibility that chemotherapy drugs may have additive effects, regardless of the mechanism, when given concurrently with radiotherapy has been the subject of study.

Reviewer name