A GCIG Intergroup Multicenter Phase III Trial of Open Label Carboplatin and Paclitaxel +/- NCI-Supplied Agent: Bevacizumab (NSC #704865) Compared With Oxaliplatin and Capecitabine +/- Bevacizumab as First Line Chemotherapy in Patients With Mucinous Epithelial Ovarian or Fallopian Tube Cancer (MEOC)

Trial ID # NCT01081262; mEOC/GOG-241
Phase III
Drug Class Chemotherapy
Drug Name Carboplatin
Alternate Drug Names Paraplatin, Novoplatinum
Drugs in Trial Bevacizumab, Capecitabine, Carboplatin, Oxaliplatin, Paclitaxel
Eligible Participant

Newly diagnosed or recurrent-chemonaïve stage II-IV or recurrent-chemonaïve stage I mucinous epithelial ovarian cancer

Patients Enrolled

50

Therapy Setting

First-line

Study Design

Open-Label, Randomized

Endpoints

ORR, DCR, PFS, OS, evaluated per RECIST

Efficacy

CarboPt+Pac (n=13) vs Oxa+Cap (n=13) vs CarboPt+Pac+Bev (n=11) vs Oxa+Cap+Bev (n=13):

PFS: 36.1 vs 7.4 vs 15.4 vs 23.2 months
OS: 37.6 vs 27.8 vs 27.7 vs 55.7 months

Evaluable: CarboPt+Pac (n=9) vs Oxa+Cap (n=11) vs CarboPt+Pac+Bev (n=7) vs Oxa+Cap+Bev (n=5):
ORR: 22 (1CR, 1PR) vs 27 (2CR, 1PR) vs 43 (1CR, 2PR) vs 40% (1CR, 1PR)
DCR:  22 (1CR, 1PR) vs 72.7 (2CR, 1PR, 5SD) vs 57.1 (1CR, 2PR, 1SD) vs 100% (1CR, 1PR, 3SD)

CarboPt+Pac+/-Bev (n=24) vs Oxa+Cap+/-Bev (n=26):
PFS: 16.4 vs 14.2 months, HR: 0.84
OS: 27.7 vs 33.9 months, HR: 0.78 (0.38-1.79, p=0.48)

Bev (n=24) vs no Bev (n=26):
PFS: 18.1 vs 8.8 months, HR: 0.80
OS: 27.7 vs 32.7 months, HR: 1.04 (0.51-2.10, p=0.92)

Exploratory analysis - patients with confirmed primary mEOC:
CarboPt+Pac+/-Bev (n=10) vs Oxa+Cap+/-Bev (n=8):
PFS: 23.1 vs 38.6 months
OS: 29.3 vs 68.8 months, HR: 0.36 (0.09-1.41, p=0.14)

Clinically Significant Adverse Events

CarboPt+Pac vs Oxa+Cap vs CarboPt+Pac+Bev vs Oxa+Cap+Bev:
Serious AE:
Grade 3-4 AE: overall (61 vs 61 vs 54 vs 85%), hypertension (0 vs 30.7 vs 27.3 vs 46.2%), neutropenia (38.5 vs 7.7 vs 9.1 vs 0%), diarrhea (0 vs 0 vs 0 vs 23.1%), bleeding (0 vs 0 vs 0 vs 15.4%), hand-foot syndrome (0 vs 0 vs 0 vs 15.4%), nausea/vomiting (0 vs 0 vs 0 vs 15.4%), anemia (7.7 vs 0 vs 0 vs 15.4%), neuropathy (15.4 vs 0 vs 0 vs 0%), thromboccytopenia (15.4 vs 0 vs 0 vs 0%)

Conclusion

No firm conclusion about best treatment options for mucinous ovarian cancer can be made, however, slight evidence suggests that oxaliplatin/capecitabine should be investigated further

Reference

Gore M et al. An international, phase III randomized trial in patients with mucinous epithelial ovarian cancer (mEOC/GOG 0241) with long-term follow-up: and experience of conducting a clinical trial in a rare gynecological tumor. Gynecol Oncol (2019) 153(3):541-548
https://pubmed.ncbi.nlm.nih.gov/31005287/

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