eUpdate – Cancer of the Pancreas Treatment Recommendations

eUpdate – Cancer of the Pancreas Treatment Recommendations

Published: 20 June 2017. Authors: ESMO Guidelines Committee

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).