GYN Studies

Cervical Cancer

GOG 92

Eligiblity

  • 137 patients with Stage IB cervical cancer with negative lymph nodes
  • 2 or more of the following features
    • more than one third (deep) stromal invasion
    • capillary lymphatic space involvement
    • and tumor diameter of 4 cm or more.

Treatment

  • postoperative external-beam irradiation to the standard pelvic field vs observation
  • RT: 46 Gy in 23 fractions to 50.4 Gy in 28 fractions.

Results by Treatment Regimen

Radiation therapy (N = 137) No further therapy (N = 140) p-value
Actural Survival 119 (86.9%) 110 (78.6%) sig not given
Site of recurrence
No evidence of disease 116 (84.7%) 101 (72.1%)
Recurrences 21 (15.3%) 39 (27.9%) p = 0.0019, single-tail
----Local 18 (13.1%) 27 (19.3%)
----Distal 3 (2.2%) 10 (7.1%)
Unknown 0 (0.0%) 2 (1.4%)
Toxicity
Hematologic 3 (2.3) 1 (0.7)
Gastrointestinal 3 (2.3) 0 (0.0)
Genitourinary 4 (3.1) 2 (1.4)
  • Local: vaginal and/or pelvis
  • distant: lung, abdomen, brain, bone, lymphnodes.

Conclusion:

  • RT appears to be particularly beneficial for patients with adenocarcinoma or adenosquamous histologies.
  • reduction in risk of recurrence (p = 0.007)
  • significant reduction in risk of progression or death (p = 0.009)

Endometrial Cancer

Comparison of GOG 99 and PORTEC

Trials Staging High-risk group High-risk Factors 3/4 GI toxicity
GOG 99 Surgical Lymphadenectomy • any age and 3 risk factors;
• age > 50 and 2 risk factors;
• age > 70 and 1 risk factor.
• G2/G3
• outer 1/3 invasion
• LVI+
• (age)
8% (which included Lymphadnectomy)
PORTEC No Surgical Lymphadenectomy • 2 or more risk factors • Grade 3
• >= 60 year-old
• IC or more
3% (no lymphadnectomy)

GOG #99
Eligibility

  • Low/intermediate risk stage I s/p surgery
  • most were low risk with 80% grade 1 or 2, and 60% IB.

High intermediate risk (HIR) subgroup of patients was defined as 3+ risk factors;

  • > 50 y.o.
  • > 70 y.o.
  • G2/G3 tumor
  • LVI+
  • outer 1/3 myometrial invasion;

Treatment

  • Surgery
    • TAH-BSO
    • pelvic and par-aortic lymphadenectomy
  • Radiation
    • 50.4 Gy to post-op Pelvis

Results

Groups Local regional failure 2 yrs RFS-4 OS-4 Grade 3/4 GI complications
Surgery 12% 81% 86% 1%
Surgery + RT 3% 91% 92% 8%
p-value < 0.01 0.007 0.56 NS

Conclusions

  • No vault recurrence in XRT arm if pt. Received radiation
  • No survival benefit to XRT arm

PORTEC (IJROBP 05)[2]
Eligibility

  • Stage I
  • no surgical LN assessment

High-risk groups 2+ risk factors

  • Grade 3
  • >= 60 year-old
  • IC or more
  • Note: patients with G3 & IC was excluded from the trial

Treatment

  • Surgery: TAH-BSO
  • Radiation: 46 Gy WPRT

Results

Groups 10-LRR 10-OS 10-CSD
TAH/BSO 14% 73% 9%
TAH/BSO + WP RT 46 Gy 5% 66% 11%
p-value <.01 .09 .47
  • LRR: localregional relapse rate
  • CSD: cancer specific deaths

GOG #122

  • 388 patients randomized WAR vs AP (cisplatin + doxorubicin)
  • 25% papillary serous or clear cell
  • 59% WAR vs 70% AP OS-2 (despite a similar PFS ?salvage)
  • Recurrence predominately pelvis and abdomen in both arms.
WAR AP
Total recurrences 54% 50%
Initial site of recurrence
Pelvis 13% 18%
Abdomen 16% 14%
Extra-abdominal or liver 22% 18%
  • Greater toxicity with AP - 4% (8) death in AP arm vs 2% (5) in WAR
  • AP is better for all subgroups of stage III and IV
Bibliography
1. Rotman M, Sedlis A, Piedmonte MR, Bundy B, Lentz SS, Muderspach LI, Zaino RJ. A phase III randomized trial of postoperative pelvic irradiation in Stage IB cervical carcinoma with poor prognostic features: follow-up of a gynecologic oncology group study. Int J Radiat Oncol Biol Phys. 2006 May 1;65(1):169-76. Epub 2006 Jan 19. PMID: 16427212
2. Scholten AN, van Putten WL, Beerman H, Smit VT, Koper PC, Lybeert ML, Jobsen JJ, Warlam-Rodenhuis CC, De Winter KA, Lutgens LC, van Lent M, Creutzberg CL; PORTEC Study Group. Postoperative radiotherapy for Stage 1 endometrial carcinoma: long-term outcome of the randomized PORTEC trial with central pathology review. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):834-8. Epub 2005 May 31. PMID: 15927414
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