The European Medicines Agency Review of Eribulin for the Treatment of Patients with Locally Advanced or Metastatic Breast Cancer: Summary of the Scientific Assessment of the Committee for Medicinal Products for Human Use

Elias Pean; Sigrid Klaar; Eva Gil Berglund; Tomas Salmonson; Jeanett Borregaard; Kenneth F. Hofland; Jens Ersbøll; Eric Abadie; Rosa Giuliani; Francesco Pignatti

doi:10.1158/1078-0432.CCR-11-3075

DOI: 10.1158/1078-0432.CCR-11-3075 Published September 2012

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Figure 1.
Chemical structure and numbering system of eribulin. Image courtesy of EMA European public assessment report for Halaven. Structural formula of eribulin mesylate (E7389).
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Figure 2.
Overall survival: Kaplan–Meier estimates of the survival function by treatment group for the data from the updated analysis (intent-to-treat population). Image courtesy of EMA European public assessment report for Halaven.

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Table 1.

Summary of selected baseline characteristics (ITT population: study 305)

	Treatment group		Total
Parameter	Eribulin N = 508, n (%)	TPC N = 254, n (%)	N = 762, n (%)
Time since original diagnosis, y
Median	5.4	5.1	5.2
Tumor sites in >10% patients overall, n (%)
Bone	306 (60.2)	158 (62.2)	464 (60.9)
Liver	296 (58.3)	159 (62.6)	455 (59.7)
Lymph nodes	220 (43.3)	118 (46.5)	338 (44.4)
Lung	197 (38.8)	95 (37.4)	292 (38.3)
Pleura	87 (17.1)	42 (16.5)	129 (16.9)
Breast	54 (10.6)	24 (9.4)	78 (10.2)
Number of organs involved, n (%)^a
1	85 (16.7)	35 (13.8)	120 (15.7)
2	172 (33.9)	82 (32.3)	254 (33.3)
3	145 (28.5)	77 (30.3)	222 (29.1)
4	71 (14.0)	37 (14.6)	108 (14.2)
5	24 (4.7)	16 (6.3)	40 (5.2)
≥6	9 (1.8)	7 (2.8)	16 (2.1)
HER2/neu status (combined FISH and IHC tests), n (%)^b
Positive	83 (16.3)	40 (15.7)	123 (16.1)
Negative	373 (73.4)	192 (75.6)	565 (74.1)
Unknown	4 (0.8)	0 (0)	4 (0.5)
Not done	48 (9.4)	22 (8.7)	70 (9.2)
ER status, n (%)
Positive	336 (66.1)	171 (67.3)	507 (66.5)
Negative	143 (28.1)	72 (28.3)	215 (28.2)
Unknown	1 (0.2)	0 (0)	1 (0.1)
Not done	28 (5.5)	11 (4.3)	39 (5.1)
PgR status, n (%)
Positive	254 (50.0)	123 (48.4)	377 (49.5)
Negative	197 (38.8)	102 (40.2)	299 (39.2)
Unknown	1 (0.2)	0 (0)	1 (0.1)
Not done	56 (11.0)	29 (11.4)	85 (11.2)
Negative for ER, PgR, and HER2/neu, n (%)
Yes	93 (18.3)	51 (20.1)	144 (18.9)
No	380 (74.8)	192 (75.6)	572 (75.1)
Unknown^c	35 (6.9)	11 (4.3)	46 (6.0)
Cancer stage at diagnosis
0	2 (0.4)	0 (0)	2 (0.3)
I	62 (12.2)	30 (11.8)	92 (12.1)
II	213 (41.9)	89 (35.0)	302 (39.6)
III	142 (28.0)	71 (28.0)	213 (28.0)
IV	81 (15.9)	59 (23.2)	140 (18.4)
Not available	8 (1.6)	5 (2.0)	13 (1.7)

Abbreviations: ER, estrogen receptor; HER2/neu, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ITT, intent to treat; PgR, progesterone receptor.

↵^aThe number of organs involved is based on the local evaluation.
↵^bFor patients who were tested with FISH their status is derived from the FISH test irrespective of IHC results even if the FISH test yielded a result of unknown. Results from the IHC tests are used only when the FISH test was not conducted. For these patients, a result of 3+ indicates that the patient was Her2/neu positive.
↵^cIncludes patients whose results were ER and PgR negative and who were never tested for their Her2 status (n = 26 and 10 for eribulin and TPC, respectively).