1. LION (Phase III Trial): Lymphadenectomy for LN-Negative Advanced Ovarian Cancer Following Complete Resection
CCO Independent Conference Highlights* of the 2017 ASCO Annual Meeting; June 2-6, 2017; Chicago, Illinois
*Clinical Care Options (CCO) is an independent medical education organization that provides conference coverage and other unique educational programs for healthcare professionals
LN, lymph node.
This activity is supported by educational grants from AbbVie, Amgen, AstraZeneca, Celgene Corporation, Genentech, Halozyme, Incyte, and Merck & Co., Inc.

2. Lymphadenectomy in Resected, LN-Negative Advanced Ovarian Cancer: Background
In pts with advanced ovarian cancer
Upfront surgery achieving macroscopic complete resection part of current standard of care[1]
Randomized trial of systematic pelvic and para-aortic LNE demonstrated significant improvement in PFS, but not OS, in pts with little to no residual disease[2]
Retrospective analysis of phase III data suggested potential OS benefit of LNE in pts without gross residual disease[3]
Current prospective, randomized phase III trial investigated PFS and OS benefits of LNE in pts with LN-negative advanced ovarian cancer following macroscopic complete resection[4]
LN, lymph node; LNE, lymphadenectomy.
1. Goff BA. J Gynecol Oncol. 2013;24: Panici PB, et al. J Natl Cancer Inst. 2005;97: du Bois A, et al. J Clin Oncol. 2010;28: Harter P, et al. ASCO Abstract 5500.
Slide credit: clinicaloptions.com

3. LION: Study Design
Multicenter, prospective, randomized, open-label phase III trial
All centers required to demonstrate surgical skill prior to participation
Primary endpoint: OS
Secondary endpoints: PFS, QoL, number of resected LN
Stratified by center, age, ECOG PS
Adult pts with suspected or proven FIGO stage IIB-IV epithelial ovarian cancer, macroscopic complete resection, ECOG PS 0/1, and clinically/ radiologically negative pelvic and para-aortic LN; no prior CT or LN dissection (N = 647)
Lymphadenectomy
(n = 323)
No lymphadenectomy
(n = 324)
CT, chemotherapy; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; LN, lymph node; PS, performance status; QoL, quality of life.
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

4. LION: Baseline Characteristics
LNE
(n = 323)
No LNE
(n = 324)
Median age, yrs (range)
60 (21-83)
60 (23-78)
ECOG PS, n (%) 1
272 (84.2)
51 (15.8)
280 (86.4)
44 (13.6)
Histologic diagnosis, n (%)
Before registration
Ovarian, fallopian tube, peritoneal
Other
106 (32.8)
304 (94.1)
19 (5.9)
106 (32.7)
303 (93.5)
21 (6.5)
Median pre-op CA 125, U/mL (IQR)
416
( )
347
( )
Characteristic, n (%)
LNE
(n = 323)
No LNE
(n = 324)
Final FIGO stage
I-IIA
IIB-IIIA
III-IV
Missing
15 (4.6)
41 (12.7)
261 (80.8)
6 (1.9)
17 (5.2)
52 (16.0)
244 (75.3)
11 (3.4)
Histology
Grade 2/3 serous
Other
234 (72.4)
89 (27.6)
227 (70.1)
97 (29.9)
ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; IQR, interquartile range; LNE, lymphadenectomy; PS, performance status.
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

5. LION: Characteristics of Surgery
Characteristic, n (%)
LNE
(n = 323)
No LNE
(n = 324)
Bilateral salpingo-oophorectomy*
319 (98.8)
320 (98.8)
Hysterectomy*
321 (99.4)
322 (99.4)
Omentectomy
(Partial) peritonectomy
Pelvis
Paracolic
Diaphragm
291 (90.1)
276 (85.5)
193 (59.8)
173 (53.6)
291 (89.8)
278 (85.8)
208 (64.2)
196 (60.5)
Characteristic, n (%)
LNE
(n = 323)
No LNE
(n = 324)
GI tract resection
Stoma
169 (52.3)
34 (10.5)
167 (51.5)
24 (7.4)
Splenectomy
62 (19.2)
56 (17.3)
Porta hepatis/lesser omentum
61 (18.9)
69 (21.3)
Partial pancreatectomy
7 (2.1)
Partial hepatectomy
27 (8.4)
28 (8.6)
Pleurectomy
20 (6.2)
Complete resection
321 (99.4)
322 (99.4)
GI, gastrointestinal; LNE, lymphadenectomy
*Includes procedures performed earlier.
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

6. LION: Efficacy and QoL Outcomes
All Pts (N = 647)
Median OS, mos (95% CI)
5-yr OS, %
67.2 ( )
55.9
Median PFS, mos (95% CI)
25.5 ( )
Outcome, Mos
LNE
(n = 323)
No LNE
(n = 324)
HR (95% CI)
P Value
Median OS
65.5
69.2
1.057 ( )
.65
Median PFS
25.5
1.106 ( )
LNE, lymphadenectomy; QoL, quality of life.
No difference in QoL between arms at baseline, discharge, end of chemotherapy, or 6 mos post chemotherapy
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

7. LION: Intraoperative Outcomes
LNE
(n = 323)
No LNE
(n = 324)
Difference
P Value
Study procedure per randomization, n (%)
320 (99.1)
313 (96.6)
Median total resected LN (IQR)
Para-aortic
Pelvic
57 (45-73)
22 (16-33)
35 (26-43)
LN metastases, n (%)
180 (55.7)
Median surgery duration, min (IQR)
340 ( )
280 ( )
+ 1 hour
< .001
Median blood loss, mL (IQR)
650 ( )
500 ( )
+ 150 mL
Transfusions, n (%)
Massive (> 10 RBC/24 hrs)
205 (63.7)
7 (2.2)
181 (56.0)
2 (0.6)
+ 8%
.005
.09
Fresh-frozen plasma, n (%)
117 (36.3)
96 (29.7)
+ 7%
.07
Intermediate/intensive care unit, n (%)
250 (77.6)
223 (69.4)
.01
IQR, interquartile range; LN, lymph node; LNE, lymphadenectomy; RBC, red blood cell.
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

8. LION: Postoperative Outcomes
Outcome, n (%)
LNE (n = 323)
No LNE (n = 324)
P Value
Infections requiring antibiotics
83 (25.8)
60 (18.6)
.03
Asymptomatic lymph cysts
14 (4.4)
1 (0.3)
< .001
Symptomatic lymph cysts
10 (3.1)
.001
Readmission
40 (12.4)
27 (8.3)
.09
Relaparotomy for complications
21 (6.5)
.01
60-day post-op mortality
3 (0.9)
.049
Platinum/taxane chemotherapy
257 (79.6)
274 (84.6)
IQR, interquartile range; LNE, lymphadenectomy
No statistically significant difference between arms in rates of fever, sepsis, thrombosis, pulmonary embolism, secondary wound healing, prolonged ileus, peripheral sensory/motor neurologic events, fistula
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

9. LION: Conclusions
In pts with advanced ovarian cancer, intra-abdominal complete resection, and clinically/radiologically negative lymph nodes:
Median OS: 67.2 mos; 5-yr OS: 55.9%; median PFS: 25.5 mos
Systemic pelvic and para-aortic LNE
Did not improve OS or PFS despite removal of subclinical LN metastases in 56% of pts
Significantly increased postoperative morbidity and mortality
Investigators conclude that systematic LNE not recommended in this pt population
LN, lymph node; LNE, lymphadenectomy.
Slide credit: clinicaloptions.com
Harter P, et al. ASCO Abstract 5500.

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