Cisplatin, radiation and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma
Disease site
Cervix
Pubmed link
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.