Treatment of (bulky) stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: a phase III trial of the Gynecologic Oncology Group.
Study Reviewed by: Anthony Costales
First Author: Eddy GL
Study hypothesis: Addition of neoadjuvant chemotherapy prior to radical hysterectomy in bulky IB cervical cancer improves survival
Standard Arm: Type III radical hysterectomy, pelvic/para-aortic lymph node dissection
Experimental Arm: Neoadjuvant vincristine 1 mg/m2 and cisplatin 50 mg/m2 every 10 days x 3 cycles followed by type III radical hysterectomy and pelvic & para-aortic lymph node dissection
Both arms:
If positive pelvic lymph nodes or parametrial margins: 45 Gy to pelvis LDR VBT to raise point A to 85 Gy and point B to 60 Gy
If positive para-aortic Lymph nodes: Extended field RT LDR VBT to raise point A to 85 Gy and point B to 60 Gy
Study population:
Inclusion: Squamous or adeno-, IB, tumor diameter ≥4 cm
Exclusion: prior pelvic radiation, prior chemo, prior hyst, no extrauterine mets
Primary endpoint: PFS, OS
Secondary endpoints: Toxicity, sites of recurrence
Arm distribution:
-Arm 1 (Rad Hyst): 143 (Squamous- 77%, adeno- 18%); Post surgical RT: 52%
-Arm 2 (NACT Rad Hyst): 145 (Squamous- 78%, adeno- 22%); Post surgical RT: 45%
Of note, 29% (48 pts) in the surgery arm received adjuvant treatment
Results
Outcome | Rad hyst | NACT Rad hyst | P value |
---|---|---|---|
3 yr PFS | 60.4% | 59.7% | NS |
3 yr OS | 69.3% | 67.7% | NS |
Outcome | Rad hyst | NACT Rad hyst | P value |
---|---|---|---|
5 yr PFS | 53.8% | 56.2% | NS |
5 yr OS | 60.7% | 63.3% | NS |
Adverse events | Rad hyst | NACT Rad hyst | SS |
---|---|---|---|
G3/ GU | 7% | 1% | Yes |
Summary:
-NACT followed by radical hysterectomy did not improve PFS or OS as compared to radical hysterectomy alone.
-The GOG recommends, based on this study, against NACT for patients with stage IB2 cervical cancer.
-This study was closed early because of slow accrual, likely secondary to the Sedlis criteria publication
For bulky IB (≥4 cm) that undergo radical hysterectomy, approximately 50% will require adjuvant radiation
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