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
page revision: 21, last edited: 15 May 2008 16:17