Irinotecan and chronomodulated infusion of 5-fluorouracil and folinic acid in the treatment of patients with advanced colorectal carcinoma

Garufi, Carlo; Dogliotti, Luigi; Dattino, R; Tampellini, Marco; Aschelter, Anna Maria; Pugliese, Patrizia; Perrone, Maria Grazia; Nisticò, C.; Comis, Silvia; Terzoli, E.

doi:10.1002/1097-0142(20010215)91:4<712::aid-cncr1056>3.0.co;2-4

Cited by 14 publications

(4 citation statements)

References 53 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Each course consisted of daily chronomodulated delivery of 5-fluorouracil (median dose per course: 2100 mg/m 2 [range: 1200–3200]) and leucovorin (1200 mg/m 2 [500–1200]) from 22:15 to 9:45, with peak delivery at 4:00, combined with irinotecan (160 mg/m 2 [130–180] from 2:00 to 8:00, with peak delivery at 5:00 on day 1) and/or oxaliplatin (77 mg/m 2 [66–140], from 10:15 to 21:45, with peak delivery at 16:00) (Bouchahda et al, 2009; Garufi et al, 2001; Gholam et al, 2006; Giacchetti et al, 2006; Lévi et al, 2011). Chronotherapy was delivered as 4-day courses intravenously or into the hepatic artery at home and/or at the hospital.…”

Section: Methodsmentioning

confidence: 99%

Thoracic surface temperature rhythms as circadian biomarkers for cancer chronotherapy

Roche

Mohamad-Djafari

Innominato

et al. 2014

Chronobiology International

View full text Add to dashboard Cite

The disruption of the temperature circadian rhythm has been associated with cancer progression, while its amplification resulted in cancer inhibition in experimental tumor models. The current study investigated the relevance of skin surface temperature rhythms as biomarkers of the Circadian Timing System (CTS) in order to optimize chronotherapy timing in individual cancer patients. Baseline skin surface temperature at four sites and wrist accelerations were measured every minute for 4 days in 16 patients with metastatic gastro-intestinal cancer before chronotherapy administration. Temperature and rest-activity were recorded, respectively, with wireless skin surface temperature patches (Respironics, Phillips) and an actigraph (Ambulatory Monitoring). Both variables were further monitored in 10 of these patients during and after a 4-day course of a fixed chronotherapy protocol. Collected at baseline, during and after therapy longitudinal data sets were processed using Fast Fourier Transform Cosinor and Linear Discriminant Analyses methods. A circadian rhythm was statistically validated with a period of 24 h (p<0.05) for 49/61 temperature time series (80.3%), and 15/16 rest-activity patterns (93.7%) at baseline. However, individual circadian amplitudes varied from 0.04 °C to 2.86 °C for skin surface temperature (median, 0.72 °C), and from 16.6 to 146.1 acc/min for rest-activity (median, 88.9 acc/min). Thirty-nine pairs of baseline temperature and rest-activity time series (75%) were correlated (r>|0.7|; p<0.05). Individual circadian acrophases at baseline were scattered from 15:18 to 6:05 for skin surface temperature, and from 12:19 to 15:18 for rest-activity, with respective median values of 01:10 (25–75% quartiles, 22:35–3:07) and 14:12 (13:14–14:31). The circadian patterns in skin surface temperature and rest-activity persisted or were amplified during and after fixed chronotherapy delivery for 5/10 patients. In contrast, transient or sustained disruption of these biomarkers was found for the five other patients, as indicated by the lack of any statistically significant dominant period in the circadian range. No consistent correlation (r<|0.7|, p ≥ 0.05) was found between paired rest-activity and temperature time series during fixed chronotherapy delivery. In conclusion, large inter-patient differences in circadian amplitudes and acrophases of skin surface temperature were demonstrated for the first time in cancer patients, despite rather similar rest-activity acrophases. The patient-dependent coupling between both CTS biomarkers, and its possible alteration on a fixed chronotherapy protocol, support the concept of personalized cancer chronotherapy.

show abstract

Section: Methodsmentioning

confidence: 99%

Thoracic surface temperature rhythms as circadian biomarkers for cancer chronotherapy

Roche

Mohamad-Djafari

Innominato

et al. 2014

Chronobiology International

View full text Add to dashboard Cite

show abstract

“…The incidence of oral and GI mucositis varied significantly among different treatment regimens and modalities (Table 4). 60–398 Most anthracycline‐based regimens were associated with rates of oral mucositis in the 1–10% range, except when regimens included 5‐FU. Included among these are the standard regimens for adjuvant therapy in patients with breast cancer (5‐FU, doxorubicin, and cyclophosphamide; doxorubicin and cyclophosphamide; or 5‐FU, epirubicin, and cyclophosphamide) as well as regimens for patients with non‐Hodgkin lymphomas, including cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP).…”

Section: Epidemiology and Outcomesmentioning

confidence: 99%

Perspectives on cancer therapy-induced mucosal injury

Sonis

Elting

Keefe

et al. 2004

Cancer

1,246

478

View full text Add to dashboard Cite

“…The number would be higher had the authors chosen to include trials of therapies other than chemotherapy (i.e., radiation therapy, vaccines or immune therapies) but not significantly so. The studies identified represent a wide range of applications and target tumor sites, including brain [5,26], pancreatic [27], colorectal [28], bladder [29] and mixed groups [25,[30][31][32][33][34][35]. The majority of the studies assessing mixed groups looked at patients who may have been participating in different trials, but were grouped together for the purposes of QOL analysis.…”

Section: Goodmentioning

confidence: 99%

Quality of life as an endpoint in Phase I oncology clinical trials of novel chemotherapy drugs

Carlson

Garland

2005

Expert Review of Pharmacoeconomics & Outcomes Research

View full text Add to dashboard Cite

This paper examines the rationale, utility and feasibility of including quality of life as an outcome measure in Phase I trials of new applications of chemotherapy drugs. Typically, Phase I trials in oncology are designed to assess safety and maximal tolerated dose; however, it is argued that when subjectively assessed, self perceived quality of life is as important as physical toxicity. The outcomes of studies that have applied quality-of-life assessment in Phase I trials are reviewed, and recommendations are made for future research based on both methodologic and practical considerations.

show abstract

Irinotecan and chronomodulated infusion of 5-fluorouracil and folinic acid in the treatment of patients with advanced colorectal carcinoma

Cited by 14 publications

References 53 publications

Thoracic surface temperature rhythms as circadian biomarkers for cancer chronotherapy

Thoracic surface temperature rhythms as circadian biomarkers for cancer chronotherapy

Perspectives on cancer therapy-induced mucosal injury

Quality of life as an endpoint in Phase I oncology clinical trials of novel chemotherapy drugs

Contact Info

Product

Resources

About