Published: 20 June 2017. Authors: ESMO Guidelines Committee
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.
Treatment of advanced/metastatic disease - Second-line treatment
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].
| 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
|
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.
