Annual Meeting Proceedings Part 1 - American Society of Clinical ...

328s Gynecologic Cancer
5004 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
Prospective assessment of cost, morbidity, and survival associated with
lymphadenectomy in low-risk endometrial cancer. Presenting Author: Sean
Christopher Dowdy, Mayo Clinic, Rochester, MN
Background: Since 1999, patients with low-risk endometrial cancer (EC) as
defined by the Mayo criteria have preferably not undergone lymphadenectomy
(LND) at our institution. We assess survival, sites of recurrence,
morbidity, and cost per up-staged case in this low-risk cohort. Methods:
Consecutive patients with Mayo-defined low-risk EC managed without
(non-LND) and with LND were compared. Cause-specific survival (CSS) was
estimated using the Kaplan-Meier method and compared using the
log-rank test. 30-day cost analyses were equated to 2010 Medicare dollars.
Results: Among 1,393 consecutive surgically managed EC cases, 385
(27.6%) met the Mayo low-risk criteria, accounting for 34.1% of type I EC.
The 5-year CSS of the low-risk cases was 98.6 %. There were 80 LND cases
(median # nodes, 29) and 305 non-LND cases. Complications within 30
days occurred in 37.5% and 19.3% of LND and non-LND cases, respectively
(P�0.001). Nodal metastasis was identified in a single LND case
(1.3%). There were 11 recurrences, 6 of which were vaginal. Not a single
recurrence was detected in the pelvic or paraaortic nodal areas in these
385 patients, with a median follow-up of 5.4 years. The estimated
prevalence (combining surgery and surveillance) of lymph node metastasis
was 0.3%. The 5-year CSS in LND and non-LND cases was 97.3% and
99.0%, respectively (P�0.32). Patients were more than seven times as
likely to die of co-morbidities than from EC. The 30-day median cost of care
was $15,678 for LND cases compared to $11,028 for non-LND cases
(P�0.001). The estimated cost per up-staged low-risk case was $439,990
if performed via endoscopy and $327,866 via laparotomy. If the 305
non-LND cases had been subjected to LND, an estimated additional
$1,418,189 would have been expended. Conclusions: For patients with
low-risk EC as defined by the Mayo criteria, lymphadenectomy dramatically
increases morbidity and 30-day cost of care without discernible short- or
long-term benefits: CSS was 99% with a 0.3% rate of nodal metastasis. In
these low-risk patients, hysterectomy with salpingo-oophorectomy alone is
appropriate surgical management and should be standard of care.
5006 Oral Abstract Session, Sat, 3:00 PM-6:00 PM
A randomized, phase III trial of paclitaxel plus carboplatin (TC) versus
paclitaxel plus cisplatin (TP) in stage IVb, persistent or recurrent cervical
cancer: Japan Clinical Oncology Group study (JCOG0505). Presenting
Author: Ryo Kitagawa, NTT Medical Center Tokyo, Tokyo, Japan
Background: TC is a less toxic regimen in terms of milder nephropathy,
neuropathy and no need of hospitalization. This multicenter phase III trial
was designed to evaluate the clinical benefits of TC compared with TP
which is current standard chemotherapy for stage IVB or recurrent cervical
cancer. Methods: Patients (pts) with stage IVB or recurrent cervical cancer;
not amenable to curative therapy; 0-1 prior platinum; no prior taxanes; were
randomized with minimization method to either TP (T 135 mg/m2 24h d1
� P 50 mg/m2 2h d2) or TC (T 175 mg/m2 3h d1 � C AUC5 1h d1), both
for maximum 6 cycles every 21 days. Primary endpoint was overall survival
(OS). Secondary endpoints were progression-free survival (PFS), toxicities,
and the proportion of non-hospitalization periods (NHP) as a surrogate for
QoL. The trial was powered at least 70% to confirm the non-inferiority of TC
to TP (threshold hazard ratio [HR] 1.29) in terms of OS, and the planned
sample size was 250 pts with one-sided alpha 5%. HR is estimated by a
stratified Cox regression. Results: From 2/06 to 11/09, 253 pts were
enrolled. 71% pts of TP arm and TC arm each received 6 cycles. Median
follow-up is 17.4 mo. Results are as below. As an alpha level for an interim
analysis was less than 0.0001, significance level for the final analysis is
approximately 5% even after the multiplicity adjustment. Conclusions: This
first randomized controlled trial comparing carboplatin doublet with cisplatin
doublet showed significant non-inferiority of TC in terms of OS. More
feasible and less toxic TC can be recommended as the new standard
treatment for stage IVB or recurrent cervical cancer.
TP TC
OS (median) HR 0.99 (multiplicity adjusted 90%CI: 18.3 mo 17.5 mo
0.79-1.25); noninferiority p�0.032
PFS (median) HR 1.04 (95%CI: 0.80-1.35) 6.90 mo 6.21 mo
Neutropenia G3-4 85.1% 76.4%
Thrombocytopenia G3-4 3.3% 23.6%
Febrile neutropenia G3-4 16.0% 7.3%
Creatinine G2-4 9.8% 4.1%
Neuropathy (motor) G3-4 0.8% 2.4%
Neuropathy (sensory) G3-4 0% 4.9%
Early treatment discontinuation (toxicity-related) 11.4% 10.0%
NHP (p