Details

Autor(en) / Beteiligte

• Picozzi, Vincent J
• Ramanathan, Ramesh K
• Lowery, Maeve A
• Ocean, Allyson J
• Mitchel, Edith P
• O'Neil, Bert H
• Guarino, Michael J
• Conkling, Paul R
• Cohen, Steven J
• Bahary, Nathan
• Frank, Richard C
• Dragovich, Tomislav
• Bridges, Benjamin B
• Braiteh, Fadi S
• Starodub, Alexander N
• Lee, Fa-Chyi
• Gribbin, Thomas E
• Richards, Donald A
• Lee, Marie
• Korn, Ronald L
• Pandit-Taskar, Neeta
• Goldsmith, Stanley J
• Intenzo, Charles M
• Sheikh, Arif
• Manzone, Timothy C
• Horne, Heather
• Sharkey, Robert M
• Wegener, William A
• O'Reilly, Eileen M
• Goldenberg, David M
• Von Hoff, Daniel D

Titel

(90)Y-clivatuzumab tetraxetan with or without low-dose gemcitabine: A phase Ib study in patients with metastatic pancreatic cancer after two or more prior therapies

Ist Teil von

• European journal of cancer (1990), 2015-09, Vol.51 (14), p.1857

Ort / Verlag

England

Erscheinungsjahr

2015

Quelle

MEDLINE

Beschreibungen/Notizen

• For patients with metastatic pancreatic adenocarcinoma, there are no approved or established treatments beyond the 2nd line. A Phase Ib study of fractionated radioimmunotherapy was undertaken in this setting, administering (90)Y-clivatuzumab tetraxetan (yttrium-90-radiolabelled humanised antibody targeting pancreatic adenocarcinoma mucin) with or without low radiosensitising doses of gemcitabine. Fifty-eight patients with three (2-7) median prior treatments were treated on Arm A (N=29, (90)Y-clivatuzumab tetraxetan, weekly 6.5 mCi/m(2)doses×3, plus gemcitabine, weekly 200 mg/m(2) doses×4 starting 1 week earlier) or Arm B (N=29, (90)Y-clivatuzumab tetraxetan alone, weekly 6.5 mCi/m(2)doses×3), repeating cycles after 4-week delays. Safety was the primary endpoint; efficacy was also evaluated. Cytopaenias (predominantly transient thrombocytopenia) were the only significant toxicities. Fifty-three patients (27 Arm A, 26 Arm B, 91% overall) completed ⩾1 full treatment cycles, with 23 (12 Arm A, 11 Arm B; 40%) receiving multiple cycles, including seven (6 Arm A, 1 Arm B; 12%) given 3-9 cycles. Two patients in Arm A had partial responses by RECIST criteria. Kaplan-Meier overall survival (OS) appeared improved in Arm A versus B (hazard ratio [HR] 0.55, 95% CI: 0.29-0.86; P=0.017, log-rank) and the median OS for Arm A versus Arm B increased to 7.9 versus 3.4 months with multiple cycles (HR 0.32, P=0.004), including three patients in Arm A surviving >1 year. Clinical studies of (90)Y-clivatuzumab tetraxetan combined with low-dose gemcitabine appear feasible in metastatic pancreatic cancer patients beyond 2nd line and a Phase III trial of this combination is now underway in this setting.