eUpdate – Cancer of the Pancreas Treatment Recommendations
Published: 20 June 2017. Authors: ESMO Guidelines Committee
Note: Other eUpdates may have been published for these guidelines. All currently valid eUpdates can be accessed from the page displaying the full guidelines on this topic
Clinical Practice Guidelines
These updates refer to the Cancer of the pancreas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up., Ducreux M, Sa Cuhna A, Caramella C, et al. Ann Oncol 2015; 25 (Suppl 5): v56-v68.
Section
Treatment of advanced/metastatic disease - Second-line treatment
Text update
Combination of nanoliposomal irinotecan with 5-fluorouracil (5-FU) and folinic acid leucovorin (LV) has shown an improvement of OS (6.1 versus 4.2 months), PFS and ORR in the intent-to-treat population over 5-FU/LV alone. Second-line therapy of pancreatic cancer has to be considered in terms of risk benefit for the patient. For fit patients, nanoliposomal irinotecan combined with 5-FU and LV may constitute an active and tolerable second-line treatment option [LoE II; ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) v1.1 score 2].
ESMO-Magnitude of Clinical Benefit Scale (MCBS) table for new therapies/indications in cancer of the pancreasa
Therapy |
Nanoliposomal irinotecan and 5-FU/LV in metastatic disease |
|---|---|
Disease setting |
Patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy |
Trial |
Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1) [1] NCT01494506 |
Phase |
III |
Control |
5-fluorouracil and folinic acid Median OS: 4.2 months |
Absolute survival gain |
OS gain: 1.9 months |
HR (95% CI) |
OS HR: 0.67 (0.49-0.92) |
QoL/toxicity |
Similar QoL and more frequent grade 3-4 adverse events |
ESMO-MCBS scoreb |
2 (Form 2a) |
aEMA approvals from January 2016 to end January 2017.
bESMO-MCBS version 1.1 [2]
CI, confidence interval; EMA, European Medicines Agency; HR, hazard ratio; MCBS, Magnitude of Clinical Benefit Scale; OS, overall survival; QoL, quality of life.
References
- Wang-Gillam A, Li CP, Bodoky G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet 2016; 387: 545-557.
- Cherny NI, Dafni U, Bogaerts J et al. ESMO-Magnitude of Clinical Benefit Scale Version 1.1. Ann Oncol 2017 (In Press).