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GOG 123

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

Date of Publication:

April 15, 1999

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/10202166/
Hypothesis:

Does the addition of weekly cisplatin to RT and hysterectomy improve survival in women with bulky stage IB cervical cancer?

Control Arm(s):

EBRT 4500cGyIVRT 3000cGy (cumulative 7500cGy point A, 5500cGy point B)extrafascial hysterectomy+/- lymphadenectomy

Experimental Arm(s):

EBRT 4500cGyweekly cisplatin 40mg/m2 (max 70mg), max 6 cyclesIVRT 3000cGy (cumulative 7500cGy point A, 5500cGy point B)extrafascial hysterectomy+/- lymphadenectomy

Primary End Point:

PFS

Inclusion Criteria:

stage IB cervical cancer (≥4cm)squamous, adeno, or adenosquamous

Exclusion Criteria:

lymph node involvement or suspicious thereof

Results:

no chemo (n=186) vs chemo (n=183):median f/u: 36 mos90% receive 4+ cis cycleshysterectomy specimen with cancer on path: 41% vs 52% (SS)grade 3/4 toxicity: 13% vs 35% (hematologic, GI)local recurrences: n=16 vs n=393yr PFS: 635 VS 795 (SS)3yr OS 74% vs 83% (SS)

Conclusions:

Addition of weekly cisplatin reduced risk of recurrence and improved OS in women with bulky stage IB cervical cancer treated with RT and extrafascial hysterectomy

Reviewer:
Olga T Filippova