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

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328s Gynecologic Cancer<br />

5004 Oral Abstract Session, Sat, 3:00 PM-6:00 PM<br />

Prospective assessment <strong>of</strong> cost, morbidity, and survival associated with<br />

lymphadenectomy in low-risk endometrial cancer. Presenting Author: Sean<br />

Christopher Dowdy, Mayo Clinic, Rochester, MN<br />

Background: Since 1999, patients with low-risk endometrial cancer (EC) as<br />

defined by the Mayo criteria have preferably not undergone lymphadenectomy<br />

(LND) at our institution. We assess survival, sites <strong>of</strong> recurrence,<br />

morbidity, and cost per up-staged case in this low-risk cohort. Methods:<br />

Consecutive patients with Mayo-defined low-risk EC managed without<br />

(non-LND) and with LND were compared. Cause-specific survival (CSS) was<br />

estimated using the Kaplan-Meier method and compared using the<br />

log-rank test. 30-day cost analyses were equated to 2010 Medicare dollars.<br />

Results: Among 1,393 consecutive surgically managed EC cases, 385<br />

(27.6%) met the Mayo low-risk criteria, accounting for 34.1% <strong>of</strong> type I EC.<br />

The 5-year CSS <strong>of</strong> the low-risk cases was 98.6 %. There were 80 LND cases<br />

(median # nodes, 29) and 305 non-LND cases. Complications within 30<br />

days occurred in 37.5% and 19.3% <strong>of</strong> LND and non-LND cases, respectively<br />

(P�0.001). Nodal metastasis was identified in a single LND case<br />

(1.3%). There were 11 recurrences, 6 <strong>of</strong> which were vaginal. Not a single<br />

recurrence was detected in the pelvic or paraaortic nodal areas in these<br />

385 patients, with a median follow-up <strong>of</strong> 5.4 years. The estimated<br />

prevalence (combining surgery and surveillance) <strong>of</strong> lymph node metastasis<br />

was 0.3%. The 5-year CSS in LND and non-LND cases was 97.3% and<br />

99.0%, respectively (P�0.32). Patients were more than seven times as<br />

likely to die <strong>of</strong> co-morbidities than from EC. The 30-day median cost <strong>of</strong> care<br />

was $15,678 for LND cases compared to $11,028 for non-LND cases<br />

(P�0.001). The estimated cost per up-staged low-risk case was $439,990<br />

if performed via endoscopy and $327,866 via laparotomy. If the 305<br />

non-LND cases had been subjected to LND, an estimated additional<br />

$1,418,189 would have been expended. Conclusions: For patients with<br />

low-risk EC as defined by the Mayo criteria, lymphadenectomy dramatically<br />

increases morbidity and 30-day cost <strong>of</strong> care without discernible short- or<br />

long-term benefits: CSS was 99% with a 0.3% rate <strong>of</strong> nodal metastasis. In<br />

these low-risk patients, hysterectomy with salpingo-oophorectomy alone is<br />

appropriate surgical management and should be standard <strong>of</strong> care.<br />

5006 Oral Abstract Session, Sat, 3:00 PM-6:00 PM<br />

A randomized, phase III trial <strong>of</strong> paclitaxel plus carboplatin (TC) versus<br />

paclitaxel plus cisplatin (TP) in stage IVb, persistent or recurrent cervical<br />

cancer: Japan <strong>Clinical</strong> Oncology Group study (JCOG0505). Presenting<br />

Author: Ryo Kitagawa, NTT Medical Center Tokyo, Tokyo, Japan<br />

Background: TC is a less toxic regimen in terms <strong>of</strong> milder nephropathy,<br />

neuropathy and no need <strong>of</strong> hospitalization. This multicenter phase III trial<br />

was designed to evaluate the clinical benefits <strong>of</strong> TC compared with TP<br />

which is current standard chemotherapy for stage IVB or recurrent cervical<br />

cancer. Methods: Patients (pts) with stage IVB or recurrent cervical cancer;<br />

not amenable to curative therapy; 0-1 prior platinum; no prior taxanes; were<br />

randomized with minimization method to either TP (T 135 mg/m2 24h d1<br />

� P 50 mg/m2 2h d2) or TC (T 175 mg/m2 3h d1 � C AUC5 1h d1), both<br />

for maximum 6 cycles every 21 days. Primary endpoint was overall survival<br />

(OS). Secondary endpoints were progression-free survival (PFS), toxicities,<br />

and the proportion <strong>of</strong> non-hospitalization periods (NHP) as a surrogate for<br />

QoL. The trial was powered at least 70% to confirm the non-inferiority <strong>of</strong> TC<br />

to TP (threshold hazard ratio [HR] 1.29) in terms <strong>of</strong> OS, and the planned<br />

sample size was 250 pts with one-sided alpha 5%. HR is estimated by a<br />

stratified Cox regression. Results: From 2/06 to 11/09, 253 pts were<br />

enrolled. 71% pts <strong>of</strong> TP arm and TC arm each received 6 cycles. Median<br />

follow-up is 17.4 mo. Results are as below. As an alpha level for an interim<br />

analysis was less than 0.0001, significance level for the final analysis is<br />

approximately 5% even after the multiplicity adjustment. Conclusions: This<br />

first randomized controlled trial comparing carboplatin doublet with cisplatin<br />

doublet showed significant non-inferiority <strong>of</strong> TC in terms <strong>of</strong> OS. More<br />

feasible and less toxic TC can be recommended as the new standard<br />

treatment for stage IVB or recurrent cervical cancer.<br />

TP TC<br />

OS (median) HR 0.99 (multiplicity adjusted 90%CI: 18.3 mo 17.5 mo<br />

0.79-1.25); noninferiority p�0.032<br />

PFS (median) HR 1.04 (95%CI: 0.80-1.35) 6.90 mo 6.21 mo<br />

Neutropenia G3-4 85.1% 76.4%<br />

Thrombocytopenia G3-4 3.3% 23.6%<br />

Febrile neutropenia G3-4 16.0% 7.3%<br />

Creatinine G2-4 9.8% 4.1%<br />

Neuropathy (motor) G3-4 0.8% 2.4%<br />

Neuropathy (sensory) G3-4 0% 4.9%<br />

Early treatment discontinuation (toxicity-related) 11.4% 10.0%<br />

NHP (p

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