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Breakfast Brief Prof. Prager – related abstracts

616O – Pertuzumab (P) + trastuzumab (H) + chemotherapy (CT) for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (mGC/GEJC): Final analysis of a Phase III study (JACOB)

Results

From 10 Jun 2013 to 12 Jan 2016, 388 pts were randomised to P + H + CT and 392 to PLA + H + CT. After a median OS follow-up of approx. 2 years, 504 patients had died, 242 in the P + H + CT arm (median OS 17.5 months) and 262 in the PLA + H + CT arm (median OS 14.2 months) (HR 0.84, 95% confidence interval [CI] 0.71–1.00; p = 0.0565). Median PFS was 8.5 months and 7.0 months respectively (HR 0.73, 95% CI 0.62–0.86). The safety profile was generally comparable between treatment arms except for diarrhoea (all grades: 61.6% in P + H + CT vs 35.1% in PLA + H + CT). Incidence of symptomatic and asymptomatic left ventricular systolic dysfunction was low and similar in both arms.

Conclusions

The study failed to demonstrate a statistically significant improvement in OS with the addition of P to H + CT, although a 3.3-month increase in median OS was observed. P was generally well tolerated and no new safety signals were identified. Further analyses will be presented.

Abstract: https://cslide.ctimeetingtech.com/library/esmo/browse/search/6JK#2Bb5i0Ft

 

617O – A Phase 3 Study of nivolumab (Nivo) in previously treated advanced gastric or gastroesophageal junction (G/GEJ) cancer: Updated results and subset analysis by PD-L1 expression (ATTRACTION-02)

Results

As of the data cut-off on February 25th 2017, one year after last patient enrollment, the median OS (mOS) was 5.32 months with Nivo versus 4.14 months with placebo (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.50-0.75; p < 0.0001). The OS rates were 46.4% (95% CI, 40.8-51.8) versus 34.7% (95% CI, 27.4-42.1) at 6 months and 27.6%(95% CI, 22.8-32.6) versus 11.6% (95% CI,7.2-17.1) at 12 months. Immunohistochemistry was performed for exploratory analyses of OS by PD-L1 status on pretreatment tumor biopsies obtained from 197 pts. In pts with PD-L1-positive (expression ≥1%) tumors, the mOS was 5.22 months in the Nivo (16 pts) versus 3.83 months in placebo (10 pts) (HR, 0.58; 95% CI, 0.24-1.38). In pts with PD-L1 negative (<1%) tumors, mOS was 6.05 months (115 pts) versus 4.19 months (52 pts) (HR, 0.70; 95% CI, 0.49-1.00), respectively.

Conclusions

With minimum 1-year of follow-up, long-term survival benefit of nivolumab was confirmed for patients with advanced G/GEJ cancer. Although tumor samples were available only in 40% of all enrolled patients, Nivo demonstrated benefit irrespective of PD-L1 expression in the exploratory analysis.

Abstract: https://cslide.ctimeetingtech.com/library/esmo/browse/search/2adk#2Bb5i02j3

 

623PD – A phase I and randomized phase II trial to evaluate the efficacy and safety of nab-paclitaxel (nab-P) in combination with gemcitabine (G) for the treatment of patients with ECOG 2 advanced pancreatic cancer (PDAC)

Results

Regimens arm C and arm E (days 1, 8, 15 every 28 days schedule) were selected for the phase 2 portion of the study. A total of 221 patients (111 in arm C/110 in arm E) were enrolled. Median age was 71/68 y, 51/55% were male and 91/83% had metastatic disease (liver 63/62%). Most frequent grade 3-4 toxicity per arm were anemia (12/7%), neutropenia (32/30%), thrombocytopenia (7/11%), febrile neutropenia (3/4%), asthenia (14/16%) and neurotoxicity (11/16%). There were no significant differences in 6 months OS 63/69%, response rate (RR) 24/28% and median progression free survival (PFS) 5.7/6.7 months respectively in each arm.

Conclusions

Nab-P in combination with G, both at 100 and 125 mg/m2 dose administered on a standard schedule of days 1, 8 and 15 is well tolerated and results in acceptable OS, RR and PFS in this fragile patient population.

Abstract: https://cslide.ctimeetingtech.com/library/esmo/browse/search/2nW5#2Bb540jP

 

622PD – nab-Paclitaxel (nab-P) plus gemcitabine (G) for patients (Pts) with locally advanced pancreatic cancer (LAPC): Interim efficacy and safety results from the Phase 2 LAPACT Trial

Results

A total of 101 pts with LAPC received nab-P + G induction. Median age was 65 years (range, 42-85), and median time from primary diagnosis to first dose was 27 days. Pts received a median of 5 Tx cycles (range, 1-6). A total of 60 patients (59%) completed induction. Among 93 evaluable patients, the DCR was 82% (76/93; PR, n = 33; SD ≥ 16 wks, n = 43); 12 pts had SD < 16 wks, and 5 pts (5%) had PD. The most frequent reasons for discontinuation during induction (n = 101 evaluable) were AEs (18%), PD (7%), and physician decision (5%). The 2 most common grade ≥ 3 AEs were neutropenia (37%) and anemia (9%). Grade ≥ 3 peripheral sensory neuropathy was reported in 4% of pts. After completion of induction, 42 patients received protocol-specific IC therapy: 13 continued nab-P + G, 15 received CRT, and 14 underwent surgery (R0, n = 4; R1, n = 6; R2, n = 1; 3 missing; resection conversion rate = 33%).

Conclusions

The reported DCR of 82% and PR rate of 35% for nab-P + G are promising, and there were no new safety signals compared with previous studies. These interim results suggest that nab-P + G is an appropriate LAPC Tx. NCT02301143.

Abstract: https://cslide.ctimeetingtech.com/library/esmo/browse/search/2nW5#2Bb540jP

 

475O – mFOLFOXIRI + panitumumab versus FOLFOXIRI as first-line treatment in patients with RAS wild-type metastatic colorectal cancer m(CRC): A randomized phase II VOLFI trial of the AIO (AIO-KRK0109)

Results

A total of 96 patients were randomized (63 arm A, 33 arm B). In arm A and B 20 (31.7%) and 11 (33.3%) patients belonged to cohort 2, respectively. ORR was 85.7% in arm A and 54.5% in arm B (p = 0.0013, OR 5.000; 95%-CI 1.870-13.370). DCR was 96.8% in arm A and 78.8% in arm B (p = 0.0071, OR 8.212). In arm A and B 53 (84,1%) and 25 (75.8%) tumors were left sided, 10 (15.9%) and 6 (18.2%) were located in the right colon, respectively. ORR in Arm A was 90.6% versus 60.0% (p = 0.0288, OR 6.400) and in Arm B 60.0% versus 50% (p=n.s.) for left and right located CRC, respectively. ORR between arms A and B comparing left and right sided CRC was 90.6% versus 60.0% (p = 0.0039, OR 6.400; 95%-CI 1.889-21.679) and 60.0% versus 50.0% (p= n.s.), respectively. Secondary resections in cohort 2 were 60% (n = 12) and 36.4% (n = 4) in arms A and B, respectively. Serious adverse advents grade 3-5 occured in 45.3% and 24.2% in arms A and B, respectively (p = 0.0496).

Conclusions

mFOLFOXIRI plus panitumumab results in significantly higher response rates compared to FOLFOXIRI in RAS wild-type mCRC. Response rates, however, are differential according to tumor sidedness. High secondary resection rates were observed. Toxicity is manageable in younger fit patients with ECOG 0-1. PFS, OS, QL and TR data are still immature and will be presented at the meeting.

Abstract: https://cslide.ctimeetingtech.com/library/esmo/browse/search/64c#2Bb3G0TE

 

477O – Bevacizumab (Bev) or cetuximab (Cet) plus chemotherapy after progression with bevacizumab plus chemotherapy in patients with wild-type (WT) KRAS metastatic colorectal cancer (mCRC): Final analysis of a French randomized, multicenter, phase II study (PRODIGE 18)

Results

From October 2010 to May 2015, 133 patients were included in 25 sites (1 patient ineligible): 85 males (64%), PS 0 (74, 56%), 1 (54, 41%), unknown (4, 3%). The 4-month PFS rate was 80.3% [95%CI (68.0% – 88.3%)] in Arm A and 66.7% [95%CI (53.6% – 76.8%)] in Arm B. Median PFS was 7.1 months in Arm A vs 5.6 months in Arm B (p = 0.060). Median OS reached 15.8 months in Arm A vs 10.4 months in Arm B (p = 0.073). Tumors samples were collected by a central laboratory and 95 were analysed using the KRAS/BRAF mutation analysis panel kit (KRAS exon 2,3,4 and BRAF V600E) and NRAS mutation detection kit (exons 2,3,4; Entrogen). On the whole, 81 patients were KRAS and NRAS WT (41 in Arm A and 40 in Arm B). Median PFS was respectively 7.8 months and 5.6 months in Arm A and Arm B (p = 0.076); median OS was 21.0 months in Arm A vs 10.7 months in arm B (p = 0.324). 73 were negative for the 3 genes (n = 36 and 37). Their median PFS were 8.2 months in Arm A) vs 5.7 months in arm B (p = 0.100). Median OS was 21.1 months vs 12.6 months (p = 0.365).

Conclusions

PRODIGE18 study is in favour of bevacizumab continuation beyond progression with chemotherapy cross over in WT RAS mCRC initially treated with first-line Bev plus chemotherapy.

Abstract: https://cslide.ctimeetingtech.com/library/esmo/browse/search/64c#2Bb3G0gp

 

When clinical practice demands to go beyond statistics: Adjuvant chemotherapy of colon cancer. The 3 vs 6 month story

Abstracts: https://cslide.ctimeetingtech.com/library/esmo/browse/search/pn9#2Bb5n

 

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