eUpdate – Cancer of the Pancreas Treatment Recommendations

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 pancreas*

Therapy Disease setting Trial Control Absolute survival gain HR (95% CI) QoL/toxicity MCBS score**
Nanoliposomal irinotecan and 5-FU/LV Patients with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-based therapy Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1) [1]
 
Phase III
 
NCT01494506

5-fluorouracil and folinic acid

 
Median OS: 4.2 months

OS gain: 1.9 months
 
OS HR:
0.67 (0.49-0.92)
Similar QoL and more frequent grade 3-4 adverse events
 
2 (Form 2a)

*EMA approvals from January 2016 to end January 2017.
**ESMO-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

  1. 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.
  2. Cherny NI, Dafni U, Bogaerts J et al. ESMO-Magnitude of Clinical Benefit Scale Version 1.1. Ann Oncol 2017 (In Press).