gynaecological cancers

Annals of Oncology 25 (Supplement 4): iv305–iv326, 2014
doi:10.1093/annonc/mdu338.20
gynaecological cancers
894P
PRECEDENT SUBSET ANALYSIS: SAFETY AND DISEASE
CONTROL WITH VINTAFOLIDE MONOTHERAPY FOLLOWING
DISCONTINUATION OF PEGYLATED LIPOSOMAL
DOXORUBICIN (PLD)
abstracts
Aim: Differential expression of the folate receptor (FR) in normal (low) and malignant
(high) tissues makes FRs promising therapeutic targets. The randomized phase II
PRECEDENT trial (NCT00722592) comparing vintafolide (Vinta), a folic-acid/
desacetylvinblastine conjugate, and PLD vs PLD alone in platinum-resistant ovarian
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D. Wydra1, S.A. Ghamande2, N. Gabrail3, E. Nowara4, M. Bidzinski5,
S. Depasquale6, R. Clark7, R.T. Penson8
1
Dept of Gynecology, Gynecological Oncology, and Gynecological Endocrinology,
Medical University of Gdansk, Gdansk, POLAND
2
Gynecologic Oncology, Georgia Regents University, Augusta, GA, USA
3
The Cancer Treatment and Research Facility, Gabrail Cancer Center, Canton,
OH, USA
4
Clinical and Experimental Oncology Department, Cancer Center and Institute
Gliwice Branch, Gliwice, POLAND
5
Department of Gynecological Oncology, Specialist Hospital Inflancka, Warsaw,
POLAND
6
Department of Obstetrics and Gynecology, Chattanooga’s Program in Women’s
Oncology, Chattanooga, TN, USA
7
Clinical Development, Endocyte, Inc., West Lafayette, IN, USA
8
Hematology/oncology, Massachusetts General Hospital, Boston, MA, USA
cancer (PROC) patients ( pts) demonstrated progression-free survival (PFS) benefit in
the combination arm (5.0 vs 2.7 months, respectively) and etarfolatide could predict
Vinta responders (Naumann et al, JCO. 2013;31:4400). This subset analysis evaluated
safety and disease control in pts who discontinued PLD and continued on single-agent
Vinta.
Methods: PROC pts (≥18 years) with ECOG PS of 0-2 and <2 prior systemic cytotoxic
regimens were randomized (2:1) to Vinta + PLD or PLD alone. Per protocol, pts in the
Vinta + PLD arm who had reached maximum allowable cumulative dose of PLD, or
who discontinued PLD due to unacceptable toxicity, could continue with single-agent
Vinta. Study endpoints included PFS, response rate, and safety.
Results: The intention-to-treat population was 149 pts (Vinta + PLD, n = 100; PLD,
n = 49). Twenty-two pts from the combination arm discontinued PLD and
continued on Vinta alone. The most common reasons for PLD discontinuation
were maximum permitted dose (n = 6) and hand-foot syndrome (n = 9). Median
number of cycles of Vinta alone was 4 (range: 1-16). In pts receiving only Vinta,
median time from monotherapy to progression, death, or treatment discontinuation
was 4.3 months, and median survival time was 18 months. Treatment toxicity in
these 22 pts was less during treatment with Vinta alone, compared with the
Vinta + PLD combination, for the following (respectively): gastrointestinal disorders
(9.1% vs 95.5%); skin or soft tissue disorders (9.1% vs 90.9%); hematologic
disorders (9.1% vs 77.3%).
Conclusions: Following discontinuation of PLD, Vinta monotherapy resulted in
continued disease control with a favorable side-effect profile. These data indicate a
potential benefit of continued Vinta monotherapy for patients unable to continue on
the Vinta + PLD combination.
Disclosure: R. Clark: Other substantive relationships: Employee of Endocyte; R.T.
Penson: Scientific Advisory Board Member: Endocyte Corporate-sponsored research:
Clinical Trial Funding - PI for Endocyte. All other authors have declared no conflicts of
interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
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