Abstract 6111
Background
This trial evaluated activity and safety of mFOLFOXIRI + panitumumab (P) vs FOLFOXIRI in ECOG 0-1, primarily non-resectable mCRC patients. Here, we report the quality of life data.
Methods
Prospective 2:1 randomized, phase II trial comparing mFOLFOXIRI (Ox 85 mg/m2, Iri 150 mg/m2, 5FU 3000mg/m2 cont. 48h, LV 200 mg/m2) + P 6 mg/KG (arm A) with FOLFOXIRI (Ox 85 mg/m2, Iri 165 mg/m2, 5FU 3200mg/m2 cont. 48h, LV 200 mg/m2; arm B), both arms q2w. Cohort 1: irresectable mCRC; cohort 2: chance of secondary resection of metastatic lesions. Primary endpoint was ORR, secondary endpoints were secondary resection rate (cohort 2), toxicity, quality of life (QoL, QLQ-C30). Between-treatment differences in QoL were assessed from baseline to disease progression, and to discontinuation of 1st-line treatment, using analysis of covariance (ANCOVA).
Results
A total of 96 patients were randomized (63 arm A, 33 arm B). There were significantly higher ORR (87.3% vs. 60.6%, p = 0.004), ETS (85.7% vs 60.0%, p = 0.01) and DpR (58.9% vs. 40.9%) in the P arm compared to FOLFOXIRI alone. QoL analyses was performed in 51 patients in arm A and 26 patients in arm B. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Although significantly more secondary resections of metastases were achieved in the P arm of cohort 2 (75.0% vs. 36.4%, p = 0.05), QoL was not different between cohorts 1 and 2 and the treatment arms, respectively. Toxicity or patient wish as the reason for end of therapy were not different between the treatment arms A and B (12.7% vs. 21.2% and 0% vs 6.1%, respectively). Grade III/IV toxicities were numerically higher in the P arm (81.3% vs. 66.7%). This increase was mainly due to toxicities such as diarrhea (25.0% vs 12.1%), mucositis (9.4 vs. 0%), rash (14.1% vs. 0%), and fatigue (7.8% vs. 0%).
Conclusions
mFOLFOXIRI plus P results in significantly higher response rates compared to FOLFOXIRI in RAS wild-type mCRC. Although toxicity was increased, QL reporting was similar in both arms. Therefore, intensive upfront therapy with modified FOLFIRINOX+P represents a valuable treatment option in patients with the need of a highly active 1st-line therapy.
Clinical trial identification
NCT01328171.
Editorial acknowledgement
Legal entity responsible for the study
Arbeitsgemeinschaft Internistische Onkologie (AIO).
Funding
Amgen.
Disclosure
M. Geissler: Honoraria (institution), Advisory / Consultancy: Amgen. D. Modest: Honoraria (institution), Advisory / Consultancy: Amgen. V. Heinemann: Honoraria (institution), Advisory / Consultancy: Amgen. All other authors have declared no conflicts of interest.
Resources from the same session
3902 - The efficacy of preoperative breast cancer chemotherapy without anti-HER2-targeted treatment – single center experience in setting of no reimbursement in Poland (2011-2015)
Presenter: Agnieszka Badora-Rybicka
Session: Poster Display session 2
Resources:
Abstract
4733 - A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial)
Presenter: Jean-Marc Nabholtz
Session: Poster Display session 2
Resources:
Abstract
5227 - Outcome of Non-metastatic Male Breast Cancer: 222 patients
Presenter: Ulku Yalcintas Arslan
Session: Poster Display session 2
Resources:
Abstract
5943 - Effects of delayed initiation of adjuvant trastuzumab for non-metastatic, Her2 positive breast cancer in a limited resources setting: ML25232 study final results
Presenter: Samir Beslija
Session: Poster Display session 2
Resources:
Abstract
1725 - Final results of scalp cooling for hair preservation: A single- institution prospective study.
Presenter: Dario Loparco
Session: Poster Display session 2
Resources:
Abstract
3713 - Adjuvant Systemic Therapy in Women with Early Breast Cancer and Intermediate Prosigna ROR Scores: Is Chemotherapy Use Declining? Evidence From a Large Practice
Presenter: Lowell Hart
Session: Poster Display session 2
Resources:
Abstract
818 - Management of early breast cancer in women over 90: A 10 year experience
Presenter: Emily Coffey
Session: Poster Display session 2
Resources:
Abstract
1141 - Evolution in the risk of adverse events of adjuvant endocrine therapy in postmenopausal women with early- stage breast cancer.
Presenter: Daniel Reinhorn
Session: Poster Display session 2
Resources:
Abstract
2277 - Hepatitis B screening and incidence of flare among non-metastatic breast cancer patients treated with anthracyclines
Presenter: Zewen Zhang
Session: Poster Display session 2
Resources:
Abstract
2781 - Effect of denosumab on low bone mineral density in postmenopausal Japanese early breast cancer patients receiving aromatase nhibitors : 36-month results
Presenter: Koichi Sakaguchi
Session: Poster Display session 2
Resources:
Abstract