Continuous, low-dose capecitabine for patients with recurrent colorectal cancer

Romiti, Adriana; Onesti, Concetta Elisa; Roberto, Michela; Barucca, Viola; Tomao, Silverio; D’Antonio, Chiara; Durante, Valeria; Milano, Annalisa; Falcone, Rosa; Rocco, Roberta Di; Righini, Riccardo; Marchetti, Paolo

doi:10.1007/s12032-015-0496-z

Cited by 26 publications

(13 citation statements)

References 21 publications

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“…Lastly, more randomized prospective studies are warranted to elucidate optimal single oral agent, including new drugs such as TS-1 or TAS-102 [ 25 ]. At the same time, more clinical studies on efficacy and tolerability of altered administration schedule of oral chemotherapeutic agents such as metronomic chemotherapy are needed to determine treatment option for very elderly CRC patients [ 26 , 27 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical characteristics and treatment propensity in elderly patients aged over 80 years with colorectal cancer

Jung

Kim

Jang

et al. 2018

Korean J Intern Med

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Background/AimsElderly patients (≥ 80 years) with colorectal cancer (CRC) tend to avoid active treatment at the time of diagnosis despite of recent advances in treatment. The aim of this study was to determine treatment propensity of elderly patients aged ≥ 80 years with CRC in clinical practice and the impact of anticancer treatment on overall survival (OS).MethodsMedical charts of 152 elderly patients (aged ≥ 80 years) diagnosed with CRC between 1998 and 2012 were retrospectively reviewed. Patients’ clinical characteristics, treatment modalities received, and clinical outcome were analyzed.ResultsTheir median age was 82 years (range, 80 to 98). Of 152 patients, 148 were assessable for the extent of the disease. Eighty-two of 98 patients with localized disease and 28 of 50 patients with metastatic disease had received surgery or chemotherapy or both. Surgery was performed in 79 of 98 patients with localized disease and 15 of 50 patients with metastatic disease. Chemotherapy was administered in only 24 of 50 patients with metastatic disease. Patients who received anticancer treatment according to disease extent showed significantly longer OS compared to untreated patients (localized disease, 76.2 months vs. 15.4 months, p = 0.000; metastatic disease, 9.9 months vs. 2.6 months, p = 0.001). Along with anticancer treatment, favorable performance status (PS) was associated with longer OS in multivariate analysis of clinical outcome.ConclusionsElderly patients aged ≥ 80 years with CRC tended to receive less treatment for metastatic disease. Nevertheless, anticancer treatment in patients with favorable PS was effective in prolonging OS regardless of disease extent.

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Section: Discussionmentioning

confidence: 99%

Clinical characteristics and treatment propensity in elderly patients aged over 80 years with colorectal cancer

Jung

Kim

Jang

et al. 2018

Korean J Intern Med

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“…The concept of LDM capecitabine has been successfully used predominately in breast cancer [ 16 ] but also in metastatic CRC [ 17 , 18 ]. Miger et al [ 17 ] retrospectively studied 35 patients with stage IV gastrointestinal cancer that had been treated with LDM capecitabine.…”

Section: Discussionmentioning

confidence: 99%

“…These two patients both had MAC. Romiti et al [ 18 ] retrospectively studied 68 patients with recurrent CRC that had been treated with LDM capecitabine. They concluded that the treatment was well-tolerated and that 19 % of the patients were progression free for more than 6 months.…”

Section: Discussionmentioning

confidence: 99%

From palliative to curative treatment - stage IV mucinous adenocarcinoma, successfully treated with metronomic capecitabine in combination with Bevacizumab and surgery- a case report

et al. 2015

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BackgroundMucinous adenocarcinoma (MAC) represents 6-19 % of all colorectal carcinoma. It is associated with poorer response to chemotherapy and chemoradiotherapy.Case presentationA 27-year-old Swedish woman presented with stomach pain and weight loss, and was diagnosed with locally advanced MAC in the transverse colon as well as 3 liver metastases. Neoadjuvant treatment with fluorouracil, folinic acid and oxaliplatin (FLOX) failed due to several infections, pulmonary embolism and deteriorated performance status. The patient was therefore considered palliative. Palliative treatment with metronomic capecitabine 500 mg × 2 daily and bevacizumab every other week were initiated. After 4 months of treatment the tumors had regressed and the patient was able to undergo radical surgery, thereby changing the treatment intention from palliative to curative. No adjuvant chemotherapy was given. There were no signs of recurrence 9 months later.ConclusionsThe role of the combination of metronomic capecitabine and bevacizumab in patients with MAC merits further investigation.

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“…As a consequence, many early clinical evaluations were carried out while several comparative studies are currently ongoing [ 13 ]. Particularly, metronomic capecitabine (mCAP) was tested as a single agent in patients with advanced gastrointestinal tumors with preliminary, encouraging results [ 14 , 15 , 16 ]. Although the best delivery schedule of mCAP has not yet been defined, mCAP at the dosage of 1500 mg/day, was recently demonstrated to be a moderately active, well-tolerated regimen as salvage chemotherapy in refractory, pretreated, metastatic gastrointestinal cancer [ 15 , 16 ].…”

Section: Introductionmentioning

confidence: 99%

Combination Therapy of High-Dose Rabeprazole Plus Metronomic Capecitabine in Advanced Gastro-Intestinal Cancer: A Randomized Phase II Trial

Roberto

Romiti

Mazzuca

et al. 2020

Cancers

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Background: In recent years, proton pump inhibitors (PPIs) have been investigated at high-dose to modulate tumor microenvironment acidification thus restoring chemotherapeutic sensitivity. This is the first trial to study activity and safety of repurposing high dose rabeprazole combined with metronomic capecitabine (mCAP). Methods: A phase II study in which patients with gastrointestinal cancer, refractory to standard treatments, who had a life expectancy >3 months, were blind randomized 1:1 to mCAP, 1500 mg/daily, continuously with or without rabeprazole 1.5 mg/kg bid, three days a week. The primary endpoint was 3-months progression-free survival (PFS). The secondary endpoints were clinical benefit (CB) and overall survival (OS). Safety and plasma concentrations of capecitabine and its metabolites (5′-DFUR and 5-FU) were also evaluated. Results: Sixty-seven (median age 69 years; 63% male; 84% colorectal cancer, 76% ECOG-PS £ 1; 84% pretreated with two or more lines of chemotherapy) out of 90 patients screened for eligibility, were randomized to receive mCAP+rabeprazole (n = 32) vs. mCAP (n = 35). All patients were evaluable for response. No significant difference between mCAP+rabeprazole vs. mCAP, in terms of 3-months PFS rate (HR = 1.43, 95%CI 0.53–3.85; p = 0.477), median PFS (HR = 1.22, 95%CI 0.75–2.00, p = 0.420), CB (RR = 0.85, 95%CI 0.29–2.44; p = 0.786) and median OS (HR = 0.89, 95%CI 0.54–1.48; p = 0.664) was observed. However, a 3-year OS rate of 10% and 12% was reported in the mCAP-rabeprazole and mCAP groups, respectively. Overall, no grade 3 or 4 toxicity occurred but grade 1 or 2 adverse event of any type were more frequently in the mCAP+rabeprazole group than in the mCAP (OR 2.83, 95%CI 1.03–7.79; p = 0.043). Finally, there was not statistically significant difference in the plasma concentration of capecitabine and its metabolites between the two groups. Conclusions: Although the adjunct of high dose rabeprazole to mCAP was not shown to affect mCAP activity, as PPI are being investigated worldwide as drugs to be repositioned in cancer treatment and also considering the limited sample size as well as the favorable safety profile of the combination in the present study, further clinical investigations are desirable.

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Continuous, low-dose capecitabine for patients with recurrent colorectal cancer

Cited by 26 publications

References 21 publications

Clinical characteristics and treatment propensity in elderly patients aged over 80 years with colorectal cancer

Clinical characteristics and treatment propensity in elderly patients aged over 80 years with colorectal cancer

From palliative to curative treatment - stage IV mucinous adenocarcinoma, successfully treated with metronomic capecitabine in combination with Bevacizumab and surgery- a case report

Combination Therapy of High-Dose Rabeprazole Plus Metronomic Capecitabine in Advanced Gastro-Intestinal Cancer: A Randomized Phase II Trial

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