Thyroid hormones ratio is a major prognostic marker in advanced metastatic colorectal cancer: Results from the phase III randomised CORRECT trial

2020 ◽  
Vol 133 ◽  
pp. 66-73
Author(s):  
Giuseppe Pasqualetti ◽  
Marta Schirripa ◽  
Emmanuelle Dochy ◽  
Matteo Fassan ◽  
Pina Ziranu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Thyroid Hormones ◽  
Metastatic Colorectal Cancer ◽  
Prognostic Marker ◽  
Phase Iii ◽  
Correct Trial

Phase II study for determining usefulness of FDG-PET as imaging biomarker in regorafenib treatment for metastatic colorectal cancer (JACCRO CC-12).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS772-TPS772 ◽  
Author(s):  
Masato Nakamura ◽  
Hironaga Satake ◽  
Akihito Tsuji ◽  
Tamotsu Sagawa ◽  
Akinori Takagane ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Placebo Group ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Fdg Pet ◽  
Standardized Uptake Value ◽  
Phase Iii ◽  
Imaging Biomarker ◽  
Treatment Schedule ◽  
Correct Trial

TPS772 Background: Regorafenib (rego) is a novel multikinase inhibitor. A clinical, placebo-controlled phase III study (CORRECT) showed a 1.4-month improvement in Overall Survival (OS) as compared to the placebo group (HR 0.77, p = 0.0052) for metastatic colorectal cancer (mCRC). In the CORRECT trial, the Progression Free Survival (PFS) curve showed that half of the patients in the rego group showed a similar tendency to the placebo group. The finding suggested that patients might be divided into responders and non-responders, and there might be a biomarker to predict them. Although various studies including the CORRECT trial have searched for the biomarker of rego, it still has not been established. On the other hand, tumor metabolic analysis using FDG-PET has been reported to be more sensitive than the change of tumor size using CT to predict the response of molecular targeting therapies. We conducted a prospective multicenter phase II trial to identify the usefulness of FDG-PET as an imaging biomarker for rego. Methods: The main eligibility criteria are as follows; pathologically proven mCRC, sufficient organ functions, failure of standard therapies (fluorouracil, oxaliplatin, irinotecan and any biologic agents), with tumors detected by FDG-PET. The treatment schedule consists of 160mg once-daily oral administration of rego for 3 weeks, followed by 1 week of rest. On day 28, FDG-PET is re-taken and the change of the maximum standardized uptake value (SUVmax) from that of the pre-treatment examination is evaluated. The primary endpoint is the change of SUVmax in the region with the highest value in pretreatment FDG-PET. Secondary endpoints are changes of SUVmax in top 5 regions (maximum 2 regions in one organ), OS, PFS, response rate, disease control rate, adverse events, and correlation of their clinical parameters and changes of SUVmax. Because there has been no data about early change in SUVmax when rego was used, we set the threshold value and estimate value as 0% and 10%, respectively. Assuming a one-sided alpha of 2.5% and a power of ≥ 90%, 16 subjects are required, and a target sample size of 20 patients was determined. Ten of the planned 20 patients have been enrolled. Clinical trial information: UMIN000015563.

A phase II study of lenvatinib in patients with metastatic colorectal cancer refractory to standard chemotherapy: LEMON study (NCCH1503).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3538-3538
Author(s):  
Hirokazu Shoji ◽  
Satoru Iwasa ◽  
Aya Kuchiba ◽  
Gakuto Ogawa ◽  
Mamiko Kawasaki ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Study ◽  
Elevated Serum ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Correct Trial

3538 Background: Although regorafenib significantly improved overall survival compared with placebo for patients with metastatic colorectal cancer (mCRC) refractory to standard chemotherapies in the global phase III CORRECT trial, regorafenib is often discontinued due to toxicity. Lenvatinib is an inhibitor of VEGF receptors 1–3, FGF receptors 1–4, PDGF receptors α, RET, and KIT, showing receptor inhibition profile and kinetics different from regorafenib. This phase II study was conducted to evaluate the efficacy and safety of lenvatinib in patients with mCRC refractory to standard chemotherapies. Methods: mCRC patients with measurable lesions, PS 0-1, and refractory to standard chemotherapies including fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, cetuximab or panitumumab (if RAS wild-type), and TAS-102 (trifluridine/tipiracil) were eligible. Prior treatment with regorafenib was not allowed. Patients received lenvatinib orally at a dose of 24 mg once daily in 28-day cycles until unacceptable toxicity or disease progression. The primary endpoint was disease control rate (DCR) assessed by independent central review. Secondary endpoints included safety, response rate, progression-free survival (PFS), and overall survival. The planned sample size was 30 patients to expect a DCR of 60% with a threshold DCR of 35%, one-sided alpha of 5% and power of 80%. Results: Between October 2016 to January 2018, 30 patients were enrolled. All had received prior chemotherapy; 14 (47%) and 16 (53%) had received 3 or ≥ 4 prior lines for advanced disease, respectively. The median number of lenvatinib cycles was 4 (range 1-13). Two patients achieved partial response and 19 patients had stable disease, resulting in a response rate of 6.7% and DCR of 70.0% (95% CI: 50.6-85.3%). Median PFS was 3.6 months (95% CI: 2.6-3.7). The most common grade ≥ 3 adverse events were hypertension (53%), elevated serum aspartate aminotransferase (13%), thrombocytopenia (10%), and anorexia (7%) without unexpected safety signals. Conclusions: Lenvatinib showed promising antitumor activity with acceptable toxicity for patients with mCRC refractory to standard chemotherapies. Clinical trial information: UMIN000023446.

scholarly journals Randomized phase III trial of S-1 versus capecitabine in the first-line treatment of metastatic colorectal cancer: SALTO study by the Dutch Colorectal Cancer Group

2017 ◽  
Vol 28 (6) ◽  
pp. 1288-1293 ◽  
Author(s):  
J.J.M. Kwakman ◽  
L.H.J. Simkens ◽  
J.M. van Rooijen ◽  
A.J. van de Wouw ◽  
A.J. ten Tije ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Trial ◽  
Cancer Group ◽  
First Line Treatment

Dose-escalation strategy in refractory metastatic colorectal cancer: A change in terms of cost-effectiveness

2021 ◽  
pp. 107815522199254
Author(s):  
Jacopo Giuliani ◽  
Francesco Fiorica ◽  
Giovanni Ponturo ◽  
Maurizio Azzurro ◽  
Andrea Ruzzenente ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cost Effectiveness ◽  
Metastatic Colorectal Cancer ◽  
Dose Escalation ◽  
Lower Cost ◽  
Cost Effective ◽  
Phase Iii ◽  
Controlled Trials ◽  
Pivotal Phase ◽  
Randomized Controlled

The analysis was conducted to assess the pharmacological costs of regorafenib and trifluridine/tipiracil in the treatment of refractory metastatic colorectal cancer (mCRC). Pivotal phase III randomized controlled trials (RCTs) of regorafenib and trifluridine/tipiracil in the treatment of refractory mCRC were considered. We have also considered the ReDOS trial, in order to verify if the dose-escalation strategy (practice changing for regorafenib) could influences the results. Differences in OS (expressed in months) between the different arms were calculated and compared with the pharmacological costs (at the Pharmacy of our Hospital and expressed in euros (€)) needed to get one month of OS. Trifluridine/tipiracil resulted the less expensive, with 1167.50 €per month OS-gained. The ReDOS trial further reduce costs with 510.41 €per month OS-gained in favour of regorafenib with the escalation-dose strategy. Both regorafenib and trifluridine/tipiracil can be considered economically sustainable treatments for refractory mCRC, apparently with a lower cost of trifluridine/tipiracil. The adoption of a dose-escalation strategy (ReDOS trial) could reverse the situation making regorafenib more cost-effective than trifluridine/tipiracil.

scholarly journals Quality-of-life findings from a randomised phase-III study of XELOX vs FOLFOX-6 in metastatic colorectal cancer

2009 ◽  
Vol 102 (1) ◽  
pp. 59-67 ◽  
Author(s):  
T Conroy ◽  
M Hebbar ◽  
J Bennouna ◽  
M Ducreux ◽  
M Ychou ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Iii ◽  
Phase Iii Study
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