PMID- 27206218
OWN - NLM
STAT- MEDLINE
DCOM- 20171107
LR  - 20221207
IS  - 1525-1438 (Electronic)
IS  - 1048-891X (Linking)
VI  - 26
IP  - 5
DP  - 2016 Jun
TI  - Pertuzumab Plus Chemotherapy for Platinum-Resistant Ovarian Cancer: Safety Run-in 
      Results of the PENELOPE Trial.
PG  - 898-905
LID - 10.1097/IGC.0000000000000695 [doi]
AB  - OBJECTIVE: In platinum-resistant ovarian cancer, adding pertuzumab to gemcitabine 
      improved progression-free survival in the subgroup with low tumor HER3 messenger 
      RNA expression. The 2-part PENELOPE trial (NCT01684878) is prospectively 
      investigating pertuzumab plus chemotherapy in this population. PATIENTS AND 
      METHODS: Part 1 evaluated pertuzumab plus either topotecan or paclitaxel. 
      Patients with platinum-refractory or platinum-resistant recurrent ovarian, 
      primary peritoneal, or fallopian tube cancer and low HER3 messenger RNA 
      expression (concentration ratio </=2.81 by central quantitative reverse 
      transcriptase-polymerase chain reaction testing on Cobas z480) received 
      intravenous pertuzumab (840 mg loading dose then 420 mg every 3 weeks) with the 
      investigator's choice of topotecan (1.25 mg/m days 1-5 every 3 weeks) or weekly 
      paclitaxel (80 mg/m) until disease progression or unacceptable toxicity. The 
      primary objective was to assess safety and tolerability. RESULTS: Fifty patients 
      were treated in part 1 (22 topotecan; 28 paclitaxel). In both cohorts, disease 
      progression was the most common primary reason for discontinuing pertuzumab, and 
      the most common all-grade adverse events (AEs) were fatigue/asthenia, anemia, and 
      diarrhea. The most common grade >/=3 AEs were anemia (36%), neutropenia (27%), and 
      fatigue/asthenia (18%) for topotecan, and peripheral sensory neuropathy (14%) and 
      anemia (11%) for paclitaxel. Two patients receiving paclitaxel-pertuzumab died 
      from AEs (abdominal infection; unexplained death). Median progression-free 
      survival was 4.1 months (95% confidence interval, 1.9-6.1) with 
      topotecan-pertuzumab and 4.2 months (95% confidence interval, 3.5-6.0) with 
      paclitaxel-pertuzumab. CONCLUSIONS: Based on part 1 tolerability, the Independent 
      Data Monitoring Committee had no objection to PENELOPE proceeding to part 2, a 
      double-blind randomized comparison of chemotherapy (topotecan, paclitaxel, or 
      gemcitabine) plus pertuzumab or placebo.
FAU - Gonzalez-Martin, Antonio
AU  - Gonzalez-Martin A
AD  - * and Medical Oncology Department, MD Anderson Cancer Center, Madrid, Spain; 
      daggerGINECO and Medical Oncology Department, Institut Gustave Roussy, Villejuif, 
      France; double daggerAGO and Department of Gynaecology, University Medical Center 
      Hamburg-Eppendorf, Hamburg, Germany;  section signCoordinating Center for Clinical Trials, 
      Philipps-University of Marburg, Marburg, Germany;  parallelMaNGO and Division of Medical 
      Gynecologic Oncology, European Institute of Oncology and University of 
      Milan-Bicocca, Milan, Italy;  paragraph signDGOG and Department of MedicalOncology, Radboud 
      University Medical Center, Nijmegen, The Netherlands; #GEICO and Department of 
      Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain; **GINECO 
      and Tenon Hospital AP-HP and Alliance Pour la Recherche en Cancerologie, France; 
      daggerdaggerAGO and Department of Gynecology and GynecologicOncology, Kliniken Essen Mitte, 
      Evang. Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany; double daggerdouble daggerMaNGO and Department 
      of Clinical and Experimental Medicine, Division of Gynecology and Obstetrics, 
      University of Pisa, Pisa, Italy;  section sign section signGEICO and Medical Oncology Department, Parc 
      Tauli Sabadell-Hospital Universitari, Sabadell, Spain;  parallel parallelGINECO and Medical 
      Oncology Department, Integrated Center for Oncology Nantes-Angers, Nantes, 
      France;  paragraph sign paragraph signAGO and National Centre for Tumour Diseases, Division of Gynaecologic 
      Oncology, University Hospital Heidelberg, Heidelberg, Germany; ##GEICO and 
      Department of Medical Oncology, Hospital Universitari Arnau de Vilanova, Lleida, 
      Spain; ***Global Medical Affairs Biometrics, and daggerdaggerdaggerGlobal Medical Affairs, F. 
      Hoffmann-La Roche Ltd; and double daggerdouble daggerdouble daggerOncology Biomarker Development at Genentech Early 
      Research and Development, Basel, Switzerland.
FAU - Pautier, Patricia
AU  - Pautier P
FAU - Mahner, Sven
AU  - Mahner S
FAU - Rau, Joern
AU  - Rau J
FAU - Colombo, Nicoletta
AU  - Colombo N
FAU - Ottevanger, Petronella
AU  - Ottevanger P
FAU - Del Campo, Josep M
AU  - Del Campo JM
FAU - Selle, Frederic
AU  - Selle F
FAU - du Bois, Andreas
AU  - du Bois A
FAU - Gadducci, Angiolo
AU  - Gadducci A
FAU - Garcia, Yolanda
AU  - Garcia Y
FAU - Berton-Rigaud, Dominique
AU  - Berton-Rigaud D
FAU - Marme, Frederik
AU  - Marme F
FAU - Ortega, Eugenia
AU  - Ortega E
FAU - Martin, Nicolas
AU  - Martin N
FAU - Bastiere-Truchot, Lydie
AU  - Bastiere-Truchot L
FAU - Kiermaier, Astrid
AU  - Kiermaier A
FAU - Kurzeder, Christian
AU  - Kurzeder C
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Int J Gynecol Cancer
JT  - International journal of gynecological cancer : official journal of the 
      International Gynecological Cancer Society
JID - 9111626
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Organoplatinum Compounds)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 7M7YKX2N15 (Topotecan)
RN  - K16AIQ8CTM (pertuzumab)
RN  - P88XT4IS4D (Paclitaxel)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Cohort Studies
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Organoplatinum Compounds/pharmacology
MH  - Ovarian Neoplasms/*drug therapy
MH  - Paclitaxel/administration & dosage/adverse effects
MH  - Topotecan/administration & dosage/adverse effects
MH  - Gemcitabine
EDAT- 2016/05/21 06:00
MHDA- 2017/11/08 06:00
CRDT- 2016/05/21 06:00
PHST- 2016/05/21 06:00 [entrez]
PHST- 2016/05/21 06:00 [pubmed]
PHST- 2017/11/08 06:00 [medline]
AID - 00009577-201606000-00014 [pii]
AID - 10.1097/IGC.0000000000000695 [doi]
PST - ppublish
SO  - Int J Gynecol Cancer. 2016 Jun;26(5):898-905. doi: 10.1097/IGC.0000000000000695.