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319P - A randomized, open label, phase II study of prophylactic octreotide (OCT) to prevent/reduce the frequency and severity of diarrhea in patients (pts) receiving lapatinib (LAP) with capecitabine (CAP) for the treatment of metastatic breast cancer (mBC)

Presentation Number
Lecture Time
12:45 - 12:45
  • Peter Krivorotko (Saint Petersburg, RU)
Hall A3 - Poster Area Networking Hub, ICM M√ľnchen, Munich, Germany
12:45 - 13:45



The combination of LAP+CAP is approved for the treatment of pts with HER2+ mBC who progressed on prior therapy, which must have included anthracyclines, taxanes and trastuzumab. Octreotide long acting release (OCT) is approved for the treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid and vasoactive intestinal polypeptide-secreting tumors. Here we investigated the efficacy of the prophylactic use of OCT in the prevention or reduction of diarrhea associated with the treatment involving LAP+CAP.


Pts (N = 62) were randomized (1:1) to OCT (0.1mg/mL) + LAP (1250 mg/day) + CAP (2000 mg/m2/day) (n = 30) or LAP+CAP (n = 32), between 17-Dec-2014 and 13-Jan-2016. The primary objective was to determine the efficacy of prophylactic OCT in reducing the proportion of pts experiencing diarrhea with a severity of ≥grade 2 based on NCI-CTCAE version 4.03 during the first 3 cycles. The secondary objectives were ORR, CBR and other safety. Pearson chi-square test was used to compare the superiority of OCT+LAP+CAP arm with LAP+CAP arm.


All pts enrolled in the study (database lock: 13-Feb-2018) were female with a median age of 56.5 years, and the majority was non-Hispanic or Latino (98%). Seven (23.3%) pts in the OCT+LAP+CAP arm and 9 (28.1%) pts in the LAP+ CAP arm had at least one episode of ≥grade 2 diarrhea within the first 3 cycles. The difference between the 2 arms was -4.8% with 95% exact CI: (-29.2%, 20.0%) and was not statistically significant (P = 0.775). The ORR and CBR in OCT+LAP+CAP vs LAP+CAP arms was 20.0% vs 18.7%, and 23.3% vs 28.1%, respectively. Two (7%) pts from OCT+LAP+CAP arm and 3 (9%) pts from LAP+CAP arm, died due to the disease under study. The most common all grade adverse events in OCT+LAP+CAP and LAP+CAP (>15% in either arm), respectively, were diarrhea (59% vs 45%), palmar-plantar erythrodysesthesia syndrome (45% vs 33%), rash (14% vs 21%), asthenia (7% vs 21%) and anemia (3% vs 18%).


Prophylactic use of OCT did not result in a lower incidence of ≥grade 2 diarrhea in mBC pts receiving LAP+CAP. No new safety issues were identified.

Clinical trial identification


Legal entity responsible for the study

Novartis Healthcare Private Limited.


Novartis Healthcare Private Limited.

Editorial Acknowledgement

Medical editorial assistance was provided by Sai Krishna Arepalli, PhD (Novartis Healthcare Pvt Ltd).


P. Krivorotko: Personal fees: Novartis, during the conduct of the study and outside the submitted work. J.P. Zarate, C. Babanrao Pisal, L. Smith: Employee: Novartis. All other authors have declared no conflicts of interest.