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.

Pubmed

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