J Clin Oncol. 2005 Feb 1;23(4):792-9. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer.
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS.
Indiana University, Indianapolis, IN, USA. kathmill@iupui.edu
PURPOSE: This randomized phase III trial compared the efficacy and safety of capecitabine with or without bevacizumab, a monoclonal antibody to vascular endothelial growth factor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. PATIENTS AND METHODS: Patients were randomly assigned to receive capecitabine (2,500 mg/m2/d) twice daily on day 1 through 14 every 3 weeks, alone or in combination with bevacizumab (15 mg/kg) on day 1. The primary end point was progression-free survival (PFS), as determined by an independent review facility. RESULTS: From November 2000 to March 2002, 462 patients were enrolled. Treatment arms were balanced. No significant differences were found in the incidence of diarrhea, hand-foot syndrome, thromboembolic events, or serious bleeding episodes between treatment groups. Of other grade 3 or 4 adverse events, only hypertension requiring treatment (17.9% v 0.5%) was more frequent in patients receiving bevacizumab. Combination therapy significantly increased the response rates (19.8% v 9.1%; P = .001); however, this did not result in a longer PFS (4.86 v 4.17 months; hazard ratio = 0.98). Overall survival (15.1 v 14.5 months) and time to deterioration in quality of life as measured by the Functional Assessment Of Cancer Treatment--Breast were comparable in both treatment groups. CONCLUSION: Bevacizumab was well tolerated in this heavily pretreated patient population. Although the addition of bevacizumab to capecitabine produced a significant increase in response rates, this did not translate into improved PFS or overall survival.
PMID: 15681523 [PubMed - indexed for MEDLINE]
Gastrointest Cancer Res. 2009 Jul;3(4):134-40. Safety of chronic low-dose capecitabine as maintenance therapy in gastrointestinal cancers.
Sun JF, Wu RR, Norris C, Noone AM, Amankwa-Sakyi M, Slack R, Marshall JL.
Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC.
BACKGROUND: Maintenance chemotherapy is not routinely used in gastrointestinal (GI) cancers. Capecitabine is an oral formulation that is enzymatically converted to 5-fluorouracil preferentially in tumor tissue. We hypothesize that capecitabine could be used as a long-term maintenance therapy to improve outcomes in patients with high-risk GI cancers following standard chemotherapy regimens. METHODS: We conducted a retrospective study to assess the toxicity of maintenance capecitabine in 28 patients with a variety of advanced GI malignancies. Capecitabine 1,000 mg twice daily without interruption was used for the first 11 patients. The dose was reduced to 1,000 mg twice daily 5 days per week in 8 patients who developed hand-foot syndrome. The remaining patients began treatment on the same abbreviated schedule. All documented clinical adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v3.0, 2003). RESULTS: Main toxicities were grade 1/2 fatigue and hand-foot syndrome. Only one grade 3 toxicity was observed and no grade 4 toxicities were seen. We also observed a significant increase in red blood cell mean corpuscular volume in participants, which may have potential use as a biomarker to monitor therapeutic response. CONCLUSIONS: Fixed therapeutic doses of oral capecitabine 1,000 mg twice daily, 5 days on, 2 days off, can be administered chronically with a high level of safety and should be explored in larger prospective studies to demonstrate efficacy in GI malignancies, especially pancreatic and metastatic colorectal cancers.
PMID: 19742139 [PubMed - in process]
Capecitabine: Have We Got the Dose Right?
Factors that influence metabolism and toxicity of Capecitabine/Xeloda
This Review summarizes why there may indeed not be a universally applicable starting dose for capecitabine because of interpatient differences in basic physiology, pharmacogenomics and diet. This article also explores which of these factors contribute to the observed inter-regional geographical variation in capecitabine toxicity, and explains why even within a region various factors should prompt a clinician to modify the starting dose.
Sidebar: Key Points
Capecitabine is an oral fluoropyrimidine prodrug that is selectively converted within cancer cells to the active drug 5-fluorouracil.
Clinical trials have indicated that capecitabine is a safe and useful alternative to 5-fluorouracil in the treatment of solid tumors, especially when there is a desire to avoid the use of indwelling venous catheters
The starting dose of capecitabine varies in different regions of the world
Individual patient exposure to capecitabine and its active metabolites will depend upon a number of factors including age, sex, body weight, hepatorenal function, concomitant drug exposure, pharmacogenetic imprinting, and dietary folate intake.
Individual clinicians should attempt to consider as many of these factors as possible before selecting an appropriate dose of capecitabine for their patients.
BMC Cancer. 2009 Dec 17;9:446. Hyperoxia increases the uptake of 5-fluorouracil in mammary tumors independently of changes in interstitial fluid pressure and tumor stroma.
Moen I, Tronstad KJ, Kolmannskog O, Salvesen GS, Reed RK, Stuhr LE.
Department of Biomedicine, University of Bergen, Bergen, Norway. ingrid.moen@biomed.uib.no
BACKGROUND: Hypoxia is associated with increased resistance to chemo- and radiation-therapy. Hyperoxic treatment (hyperbaric oxygen) has previously been shown to potentiate the effect of some forms of chemotherapy, and this has been ascribed to enhanced cytotoxicity or neovascularisation. The aim of this study was to elucidate whether hyperoxia also enhances any actual uptake of 5FU (5-fluorouracil) into the tumor tissue and if this can be explained by changes in the interstitium and extracellular matrix. METHODS: One group of tumor bearing rats was exposed to repeated hyperbaric oxygen (HBO) treatment (2 bar, pO(2)= 2 bar, 4 exposures * 90 min), whereas one group was exposed to one single identical HBO treatment. Animals housed under normal atmosphere (1 bar, pO(2) = 0.2 bar) served as controls. Three doses of 5FU were tested for dose response. Uptake of [3H]-5FU in the tumor was assessed, with special reference to factors that might have contributed, such as interstitial fluid pressure (Pif), collagen content, oxygen stress (measured as malondialdehyd levels), lymphatics and transcapillary transport in the tumors. RESULTS: The uptake of the cytostatic agent increases immediately after a single HBO treatment (more than 50%), but not 24 hours after the last repeated HBO treatment. Thus, the uptake is most likely related to the transient increase in oxygenation in the tumor tissue. Factors like tumor Pif and collagen content, which decreased significantly in the tumor interstitium after repeated HBO treatment, was without effect on the drug uptake. CONCLUSION: We showed that hyperoxia increases the uptake of [3H]-5FU in DMBA-induced mammary tumors per se, independently of changes in Pif, oxygen stress, collagen fibril density, or transendothelial transport alone. The mechanism by which such an uptake occur is still not elucidated, but it is clearly stimulated by elevated pO(2).
PMID: 20017908 [PubMed - in process]
Breast Cancer. 2009;16(1):88-92. Epub 2008 May 14. Successful treatment of leptomeningeal metastases from breast cancer using the combination of trastuzumab and capecitabine: a case report.
Shigekawa T, Takeuchi H, Misumi M, Matsuura K, Sano H, Fujiuchi N, Okubo K, Osaki A, Aogi K, Saeki T.
Department of Breast Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan. takshige@saitama-med.ac.jp
We report a case of metastatic breast cancer with leptomeninges and multiple bone metastases that showed an excellent response to the combination of trastuzumab and capecitabine; therapeutic effect was evaluated by MRI at follow-up. A 44-year-old woman underwent modified radical mastectomy in February 1997. In April 2003, a tumor at the right basis cerebri and multiple bone metastases were noted, and in October 2003, she underwent enucleation of the tumor. Histopathologically, the tumor was consistent with a basal skull metastasis from breast cancer. In March 2004, the patient began to experience pain, weakness, and paresthesia of both legs. She was diagnosed, with leptomeningeal metastasis (LM) from breast cancer using MRI. In December 2005, the combination of trastuzumab and capecitabine administered as sixth-line treatment was very effective for LM. Although it is generally very difficult to diagnose LM and assess the therapeutic effect with MRI, in this case, it was possible. To our knowledge, there has been no report in the literature describing the combination of trastuzumab and capecitabine for LM from breast cancer. Although the mechanism underlying the efficacy of this combination is still unknown, the treatment would be worth trying because of its few side effects in extensively treated patients with LM from breast cancer. To confirm the antitumor efficacy of trastuzumab and capecitabine, however, further investigations are required.
PMID: 18478315 [PubMed - indexed for MEDLINE]
Cancer News Article Journal of Clinical Oncology on December 28, 2009.[1]
Xeloda® Adds to Effectiveness of Herceptin® and Taxotere® Regimen for Metastatic Breast CancerResearchers involved in an international multicenter study (CHAT) have reported that the addition of Xeloda® (capecitabine) to Herceptin® (trastuzumab) and Taxotere® (docetaxel) improves response rate and progression-free survival in women with advanced or metastatic HER2-positive breast cancer. However, Xeloda increased toxicities significantly. The details of this study were published early online in the Journal of Clinical Oncology on December 28, 2009.[1]
Xeloda is an active agent for the treatment of breast cancer and has the advantage of being administered orally. Herceptin is FDA approved as single-agent therapy in the treatment of HER2-positive patients with metastatic breast cancer. However, combining Herceptin with a taxane or other non-anthracycline drugs has been found to be more effective than single-agent therapy.
The CHAT trial enrolled 222 patients with advanced or metastatic HER2-positive breast cancer who had not received prior treatment except for adjuvant therapy. Preliminary results of this Phase II randomized trial were presented as a late-breaking abstract at the 2006 annual meeting of the European Society of Medical Oncology (ESMO) in Istanbul, Turkey. Table 1 shows the main findings of this trial.
Table 1:Regimen of Xeloda/Herceptin/Taxotere Versus Herceptin/Taxotere
Herceptin, Taxotere, Xeloda
Herceptin, Taxotere
Number of patients
112
110
Overall response
73%
71%
Complete response
23%
16%
Median progression-free survival
18 months
13 months
2-year overall survival
75%
66%
Febrile neutropenia
27%
15%
Grade ¾ neutropenia
77%
54%
Hand-foot syndrome
17%
<1%
Grade ¾ diarrhea
11%
4%
Congestive heart failure
1
1
.
It was concluded that the Xeloda-Herceptin-Taxotere regimen was effective first-line therapy for women with metastatic breast cancer. Comments: These authors cautioned that this therapy should be “reserved for patients with good performance status who are not receiving long-term steroids.”
Reference: J Clin Oncol. 2009 Dec 28. [Epub ahead of print] Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in HER2-Positive Metastatic Breast Cancer.
Wardley AM, Pivot X, Morales-Vasquez F, Zetina LM, de Fátima Dias Gaui M, Reyes DO, Jassem J, Barton C, Button P, Hersberger V, Torres AA.
The Christie, Manchester, United Kingdom; University Hospital of Besançon, Besançon, France; Instituto Nacional de Cancerolog*a, Mexico City, Mexico; Hospital Roosevelt, Guatemala City, Guatemala; Instituto Nacional do Câncer, Rio de Janeiro, Brazil; Hospital Center for International Medicine Advanced, San José, Costa Rica; Medical University of Gdansk, Gdansk, Poland; F. Hoffmann-La Roche Ltd, Basel, Switzerland; Roche Products Pty Ltd, Dee Why, New South Wales, Australia; and Hospital Universitario Miguel Servet, Zaragoza, Spain.
PURPOSE: To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. PATIENTS AND METHODS: Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m(2) in HTX arm, 100 mg/m(2) in HT arm, every 3 weeks) with or without X (950 mg/m(2) twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). RESULTS: In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1%) and grade 3/4 diarrhea (11% v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. CONCLUSION: HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.
PMID: 20038734 [PubMed - as supplied by publisher]
Phytomedicine. 2010 Jan 19. [Epub ahead of print] Phase I study of the botanical formulation PHY906 with capecitabine in advanced pancreatic and other gastrointestinal malignancies.
PMID: 20092990 [PubMed - as supplied by publisher]
Tumori. 2007 Mar-Apr;93(2):129-32. Intermittent capecitabine monotherapy with lower dose intensity in heavily pretreated patients with metastatic breast cancer.
Osako T, Ito Y, Takahashi S, Tokudome N, Iwase T, Hatake K.
Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo. tomo.osako@jfcr.or.jp
AIMS AND BACKGROUND: The purpose of the present retrospective study was to evaluate efficacy and safety of a lower dose-intensity capecitabine monotherapy regimen in heavily pretreated patients with metastatic breast cancer. METHODS: Patients with metastatic breast cancer who had been administered capecitabine monotherapy between June 2003 and August 2004 at our hospital were retrospectively reviewed. Oral capecitabine (828 mg/m2) was given twice daily for three weeks followed by a one-week rest period; this was repeated every four weeks. RESULTS: One-hundred and two patients were assessed. Median follow-up of patients was 16.4 months. One hundred patients (98%) had been pretreated with either anthracyclines or taxanes, 81 patients (79%) with both anthracyclines and taxanes. Response rate was 17% (95% CI, 9-24%), and clinical benefit rate was 41% (95% CI, 32-51%). Median time-to-treatment failure was 4.9 months, and median overall survival time was 24.3 months. This regimen was well tolerated. The most frequent grade 3 or 4 adverse event was hand-foot syndrome (6%). Other grade 3 or 4 adverse events were seen in only 1%-3% of patients. CONCLUSIONS: Intermittent capecitabine monotherapy with lower dose intensity achieved a high tumor control rate with low toxicity in heavily pretreated metastatic breast cancer patients.
PMID: 17557557 [PubMed - indexed for MEDLINE]
Breast Cancer. 2009 Jul 25. [Epub ahead of print] Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer.
Kusama M, Nomizu T, Aogi K, Yoshimoto M, Horikoshi N, Tabei T, Noguchi S, Miura S, Yoshimura N, Kimura M, Toyama K, Shin E.
Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan, kusama@breastcenter.jp.
BACKGROUND: A multicenter, phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent 4-week regimen of capecitabine in patients with advanced/metastatic breast cancer. METHODS: RESULTS: Fifty patients who had received no more than one prior chemotherapy regimen for advanced/metastatic disease were enrolled from 23 centers and received at least two 4-weekly cycles of capecitabine (828 mg/m(2) orally twice daily for 3 weeks followed by a 1-week rest period).The overall response rate assessed by the Independent Review Committee (standard population, n = 46) was 28.3% (95% confidence interval 16.0-43.5%), including complete responses in 6.5%. Stable disease was observed in 20 patients and maintained for more than 6 months in 10 patients. The median duration of response in 13 evaluable responders was 5.3 months. Among evaluable patients (n = 47), median time to disease progression was 5.1 months. Median overall survival was 20.2 months. The most common treatment-related adverse events (all grades) were hand-foot syndrome (66%), nausea (26%), stomatitis (22%) and diarrhea (20%). Grade 3/4 treatment-related adverse events were seen in 23 patients (46%). The most common grade 3/4 adverse events were lymphocytopenia (22%), hand-foot syndrome (18%) and hyperbilirubinemia (10%). CONCLUSIONS: Although the target overall response rate was not reached, the Japanese intermittent 4-week regimen of capecitabine was shown to be an effective and well-tolerated first- or second-line therapy for advanced/metastatic breast cancer.
PMID: 19633909 [PubMed - as supplied by publisher]
Oncology. 2009;77(5):318-27. Epub 2009 Nov 23. First-line capecitabine monotherapy for slowly progressing metastatic breast cancer: do we need aggressive treatment?
Debled M, Madranges N, Trainaud A, Floquet A, Donamaria C, Brouste V, Durand M, Mauriac L.
Department of Medical Oncology, Institut Bergonié, South-West Comprehensive Cancer Center, Bordeaux, France. debled @ bergonie.org
BACKGROUND: Primary treatment goals in less aggressive metastatic breast cancer (MBC) are prolonged survival, good quality of life and control of the disease and its symptoms. High activity, oral administration and no alopecia make capecitabine monotherapy attractive in slowly evolving disease. METHODS: We retrospectively analysed 226 patients who had received single-agent capecitabine as 1st-line chemotherapy at our institution. RESULTS: The median interval between breast cancer diagnosis and MBC was 52 months (range 0-479); 76% had received endocrine therapy for MBC, 58% had visceral involvement and 30% had 3 or more metastatic sites. The median starting dose was 1,000 mg/m(2) twice daily. Disease was improved in 56% of the patients (median duration: 13.2 months) and stabilised in 20%. Median time to treatment failure was 8.8 months (95% CI: 7.1-10.5); median overall survival from initiating capecitabine was 23.6 months (95% CI: 19.7-27.4). Prior adjuvant chemotherapy, endocrine therapy for MBC, visceral disease, hormone receptor status and initial capecitabine dose did not influence time to treatment failure. Among 161 patients <75 years, 90% received further chemotherapy. CONCLUSION: Based on these findings, 1st-line capecitabine should be considered in slowly progressing disease, offering an active, well-tolerated oral treatment with minimal toxicity and no alopecia. More toxic treatments may be reserved for more aggressive disease. Copyright 2009 S. Karger AG, Basel.
PMID: 19940523 [PubMed - indexed for MEDLINE]
Clin Breast Cancer. 2007 Dec;7(11):857-60. Safety profile and activity of lower capecitabine dose in patients with metastatic breast cancer.
Rossi D, Alessandroni P, Catalano V, Giordani P, Fedeli SL, Fedeli A, Baldelli AM, Casadei V, Ceccolini M, Catalano G.
Oncology Unit, S. Salvatore Hospital, Pesaro, Italy. d.rossi63@libero.it
PURPOSE: Capecitabine is an orally administered precursor of 5'-deoxy-5-fluorouridine that was rationally designed to generate 5-fluorouracil (5-FU) preferentially in tumor tissue. The drug enables chronic dosing that mimics continuous infusion of 5-FU. Phase II trials of capecitabine at 1250 mg/m2 twice daily for 14 days followed by 7 days of rest, is active in anthracycline- and taxane-pretreated patients; the main toxicity is palmar-plantar erythrodysesthesia, diarrhea, and nausea. To overcome these side effects, the dose has been reduced to 1000 mg/m2 twice daily with a better therapeutic profile and encouraging efficacy. The aim of our study was to confirm safety and activity of capecitabine at lower doses in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Thirty-seven patients with advanced breast cancer entered the study. The first 7 patients were treated with capecitabine 1250 mg/m2 twice daily (for 14 days followed by 7 days of rest) and the next 30 patients with capecitabine 1000 mg/m2. The median age was 62 years (range, 38-87 years). Thirteen patients were chemotherapy naive and 24 were pretreated with chemotherapy (9 patients, 1 line; 15 patients, > or = 2 lines). Anthracyclines and/or taxane schedules were administered in 22 patients. Soft tissue metastases were documented in 36 patients; visceral metastases in 24 patients; visceral and soft tissue metastases in 23 patients. RESULTS: Thirty patients were evaluable for response (5 at "higher" dose and 25 at "lower" dose) and all for toxicity. Overall objective response rate was 57% (5 complete responses and 12 partial responses); 95% CI, 39%-74%; stable disease 20% and progressive disease 23%. Eight of 13 chemotherapy-naive patients (61.5%) and 9 of 24 pretreated patients (37.5%) responded to capecitabine, according to the intent-to-treat principle (6 of 9 responses were obtained at a lower dose). Three responses at the "higher" dose and 14 at the "lower" dose were reported. Median time to progression was 7 months (range, 1-38 months) and median overall survival was 19 months (range, 2-47 months). Toxicity was as follows: grade 2/3 palmar-plantar erythrodysesthesia in 9 patients (24%), grade 2/3 asthenia in 7 patients (19%), grade 2 vomiting in 4 patients (11%), grade 2 renal toxicity in 1 patient, grade 2 skin reaction in 1 patient, and suspected cardiac toxicity in 1 patient. CONCLUSION: Our study confirmed that a lower dose of capecitabine has a good toxicity profile and is active in patients with MBC.
Cancer Chemother Pharmacol. 2010 Mar 5. [Epub ahead of print] DPD-based adaptive dosing of 5-FU in patients with head and neck cancer: impact on treatment efficacy and toxicity.
Yang CG, Ciccolini J, Blesius A, Dahan L, Bagarry-Liegey D, Brunet C, Varoquaux A, Frances N, Marouani H, Giovanni A, Ferri-Dessens RM, Chefrour M, Favre R, Duffaud F, Seitz JF, Zanaret M, Lacarelle B, Mercier C.
Medical Oncology Unit, La Timone University Hospital, 234 Rue St Pierre, 13385, Marseille cedex 05, France.
BACKGROUND: Fluoropyrimidine drugs are widely used in head and neck cancer (HNC). DPD deficiency is a pharmacogenetics syndrome associated with severe/lethal toxicities upon 5-FU or capecitabine intake. We have developed a simple, rapid, and inexpensive functional testing for DPD activity, as a means to identify deficient patients and to anticipate subsequent 5-FU-related toxicities. We present here the impact of fluoropyrimidine dose tailoring based on DPD functional screening in a prospective, open, non-controlled study, both in term of reduction in severe toxicities and of treatment efficacy. METHODS: About 65 patients with HNC (59 +/- 9 years, 52M/13F, Prospective Group) were entered into the study. Screening for DPD deficiency was performed prior to the beginning of the chemotherapy or radiochemotherapy. DPD status was evaluated by monitoring U/UH2 ratio levels in plasma as a surrogate marker for enzymatic functionality. 5-FU doses were reduced according to the extent of the detected DPD impairment, and adjusted on the basis of age, general condition, and other clinical/paraclinical covariates, if required. Treatment-related toxicities and subsequent impact on treatment delay were carefully monitored next for comparison with a retrospective, Reference subset of 74 other patients with HNC (mean age: 59 +/- 10, 58M/16F, Reference Group), previously treated in the same institute with similar schedule but using standard 5-FU dosage. RESULTS: Thirty-one out of 65 patients (48%) were identified as mildly (28%) to markedly (20%) DPD deficient. Subsequently, dose reductions ranging from 10 to 100% with 5-FU were applied in those patients. In this group, six patients (9%) experienced severe toxicities, none of them being life threatening, and no toxic death was encountered. In comparison, 16 out of 74 patients (22%) of the Reference Group displayed severe side effects after standard 5-FU administration, 13% being life-threatening toxicities (e.g., G4 neutropenia + sepsis). Moreover, one toxic death was observed in this Reference Group. No postponement or cancelation of forthcoming chemoradiotherapy courses occurred in the Prospective Group, whereas treatment had to be disrupted in six patients (8%) from the Reference Group. No difference in first-line therapy efficacy was evidenced between the two subsets (78 vs. 79% response, P = 0.790). CONCLUSIONS: Although non-randomized, this study strongly suggests that prospective determination of DPD status has an immediate clinical benefit by reducing the drug-induced toxicities incidence in patients treated with 5-FU, allowing an optimal administration of several courses in a row, while maintaining efficacy. Our preliminary results thus advocate for systematic DPD screening in patients eligible for treatment with fluoropyrimidine drugs in HNC.
PMID: 20204365 [PubMed - as supplied by publisher]
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