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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n\u003Cp id=\u0022p-1\u0022\u003EThis article discusses multiple studies using capecitabine plus oxaliplatin (XELOX),\n5-fluorouracil (5-FU), leucovorin, and oxaliplatin (FOLFOX-4), and Infusional 5-FU\/LV (FOLFOX-6), as\nwell as the the MOSAIC and XELOX-1 Trials for the treatment of metastatic colorectal cancer.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EGastrointestinal Cancers\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ENO16999 (XELOX-1) was an open-label randomized trial designed to demonstrate the non-inferiority\nof XELOX and FOLFOX-4 in patients with previously untreated metastatic colorectal cancer. The\nprimary endpoint was the non-inferiority of progression-free survival (PFS) following treatment with\nXELOX vs FOLFOX-4.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAfter pivotal phase 3 data for bevacizumab became available [Hurwitz H et al.\n\u003Cem\u003ENEJM\u003C\/em\u003E 2004], the XELOX-1 protocol was amended for all newly enrolled patients. In a\nblinded second randomization, patients received additional treatment with bevacizumab or placebo. A\nsecond primary endpoint was added: PFS of bevacizumab vs placebo in patients treated with\nchemotherapy.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe research group previously reported non-inferiority in terms of PFS of XELOX vs FOLFOX4 for\nthe whole study population. [Cassidy J et al. \u003Cem\u003EAnn Oncol\u003C\/em\u003E 2006] Two new reports\npresented at ASCO provided an update on the roles of bevacizumab and type of chemotherapy,\nrespectively, on long-term outcome.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe study presented by Leonard Saltz, MD, Memorial Sloan-Kettering Cancer Center, New York,\nfocused on progression-free and overall survival (OS) in patients enrolled after the protocol\namendment. This cohort included patients treated with FOLFOX-4 plus placebo (n=351), FOLFOX-4\nplus bevacizumab (n=349), XELOX plus placebo (n=350), and XELOX plus bevacizumab\n(n=350). The median age of patients in the FOLFOX-4 and XELOX arms was 60 and 61 years,\nrespectively. Approximately 25% of patients had received adjuvant chemotherapy prior to\nenrolling in the XELOX-1 trial.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe addition of bevacizumab to oxaliplatin-based chemotherapy significantly improved PFS (HR,\n0.83; p=0.0023). The median PFS in the bevacizumab and placebo groups was 10.4 months and 7.9\nmonths, respectively (p\u0026lt;0.0001). Time to treatment failure was 6.9 months and 6.0 months,\nrespectively (p=0.0030). The addition of bevacizumab was associated with a modest survival\nbenefit as well. Median OS was 21.3 months for bevacizumab-treated patients and 19.9 months for\nthose in the placebo group (p=0.0769).\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EPatients in the placebo group were more likely to discontinue therapy due to disease progression\nevents. Progression was the reason for treatment discontinuation in 56% of placebo recipients\ncompared with 38% of bevacizumab recipients. In contrast, a higher proportion of patients\ndiscontinued therapy because of adverse events in the bevacizumab arm (31%) compared with the\nplacebo arm (21%). Most treatment discontinuations were associated with chemotherapy-related\ntoxicities rather than bevacizumab-related events.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe majority of patients in the placebo (75%) and bevacizumab (80%) arms\nexperienced at least one grade 3\/4 adverse event. Less than 1% of patients in either group\nexperienced GI perforations.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe second analysis presented by lead author Jim Cassidy, MD, Glasgow University, Scotland,\nfocused on PFS and OS among patients treated with XELOX or FOLFOX-4. In this analysis, data from all\npatients treated with XELOX (with or without bevacizumab) were pooled and compared to data from all\npatients who received FOLFOX-4 (with or without bevacizumab).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe co-primary endpoint of the XELOX-1 study \u2013 the non-inferiority of XELOX vs FOLFOX-4\nfor PFS \u2013 was met. Median PFS was 8.0 months in the XELOX group (n=1,017) and 8.5\nmonths in the FOLFOX-4 group (n=1,017; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). OS was equivalent in the two treatment arms. In the XELOX group, median OS was\n19.8 months, compared with 19.6 months in the FOLFOX-4 group.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Primary Endpoint PFS (ITT Population).\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-528585162\u0022 data-figure-caption=\u0022Primary Endpoint PFS (ITT Population).\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11078\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n\u003Cp id=\u0022p-11\u0022 class=\u0022first-child\u0022\u003EPrimary Endpoint PFS (ITT Population).\u003C\/p\u003E\n\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-12\u0022\u003EIn addition to conducting a pooled analysis, Cassidy and colleagues evaluated XELOX vs FOLFOX-4\nonly in patients who received bevacizumab in addition to chemotherapy. In this analysis, the median\nOS was 21.4 months in the XELOX\/bevacizumab group (n=349) and 21.2 months in the FOLFOX-4\ngroup (n=350).\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003E\u201cThe rationale for this study was to replace a complex intravenous-based regimen with a\nsimple oral-based regimen,\u201d explained Dr. Cassidy. \u201cThat\u0027s what XELOX does. You\ndon\u0027t have a dent in the activity [compared with FOLFOX-4], and it\u0027s a lot easier for\npatients.\u201d\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003E\u201cThe key issue is quality of life. Instead of being in my ward, you can be at\nhome,\u201d Dr. Cassidy continued. \u201cYou see me less; you see your family more. This seems\nlike a good idea to me.\u201d\u003C\/p\u003E\u003Cp id=\u0022p-15\u0022\u003EIn a third analysis, the research group assessed survival in patients who enrolled in the trial\nprior to the protocol amendment. These patients were treated with chemotherapy only, and did not\nhave an additional randomization to bevacizumab or placebo. In this group, the median OS was 18.8\nmonths in XELOX recipients (n=317) and 17.7 months in FOLFOX-4 recipients (n=317).\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003EThe safety profiles of XELOX and FOLFOX-4 were balanced in this updated analysis. A similar\nproportion of patients in the XELOX group (26%) and FOLFOX-4 group (24%) discontinued\ntherapy due to adverse events.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n\u003Ch2 class=\u0022\u0022\u003EEfficacy and Safety Findings from a Randomized Phase 3 Study of Capecitabine plus Oxaliplatin\n(XELOX) vs Infusional 5-FU\/LV (FOLFOX-6) for Metastatic Colorectal Cancer\u003C\/h2\u003E\n\u003Cp id=\u0022p-17\u0022\u003EThis prospective, randomized, phase 3 trial was designed to demonstrate the non-inferiority of\nXELOX vs the FOLFOX-6 regimen as first-line treatment in metastatic colorectal cancer.\u003C\/p\u003E\n\u003Cp id=\u0022p-18\u0022\u003EXELOX is a combination of capecitabine (1,000 mg\/m\u003Csup\u003E2\u003C\/sup\u003E twice daily days 1\u201314) and\noxaliplatin (130 mg\/m\u003Csup\u003E2\u003C\/sup\u003E day 1). XELOX is administered every 3 weeks for a maximum of 8\ncycles. FOLFOX-6 is a combination of oxaliplatin (100 mmg\/m\u003Csup\u003E2\u003C\/sup\u003E day 1), LV (400\nmg\/m\u003Csup\u003E2\u003C\/sup\u003E over a 2-hour infusion on day 1), and 5-FU (400 mg\/m\u003Csup\u003E2\u003C\/sup\u003E intravenous bolus\nfollowed by 2,400\u20133,000 mg\/m\u003Csup\u003E2\u003C\/sup\u003E over a 46-hour infusion on day 1). FOLFOX-6 is\nadministered every 2 weeks for a maximum of 12 cycles.\u003C\/p\u003E\n\u003Cp id=\u0022p-19\u0022\u003EA total of 306 patients were randomly assigned treatment to XELOX (n=156) or FOLFOX-6\n(n=150) for 6 months and followed for a median of 18.8 months after randomization. The\nprimary endpoint was the non-inferiority of XELOX vs FOLFOX-6 for best response based on RECIST\ncriteria. Patients were evaluated for overall response (OR), a combination of complete response (CR)\nand partial response (PR). Secondary endpoints included PFS, OS, and safety.\u003C\/p\u003E\n\u003Cp id=\u0022p-20\u0022\u003EPatients in the XELOX group received a mean of 6 treatment cycles (range, 0\u20138), compared\nwith 9 mean treatment cycles (range, 0\u201312) in the FOLFOX-6 group. The median relative dose\nintensities of oxaliplatin were 99.6% and 95.4% in the XELOX and FOLFOX-6 groups,\nrespectively. Among XELOX recipients, the mean relative dose intensity for capecitabine was\n100%. For patients treated with FOLFOX-6, the mean relative dose intensity of infusional 5-FU\nwas 85.0%.\u003C\/p\u003E\n\u003Cp id=\u0022p-21\u0022\u003EThe primary outcome of this trial was achieved; XELOX was shown to be non-inferior to FOLFOX-6 in\nthis patient population, though there were slight numerical advantages to the FOLFOX-6 regimen. The\noverall response rate was 42% in the XELOX group (including 2% CR and 40% PR)\nand 46% in the FOLFOX-6 group (including 0.5% CR and 45.5% PR). Disease control\nrates \u2013 a combination of CR, PR, and stable disease \u2013 were 84% in the XELOX arm\nand 87% in the FOLFOX-6 arm.\u003C\/p\u003E\n\u003Cp id=\u0022p-22\u0022\u003E\u201cThese data show that it is possible to replace infusional 5-FU, which does not have a\nconvenient method of administration, with capecitabine, an oral agent,\u201d said lead study\nauthor Dr. Michel Ducreux, MD, Gustave Roussy Institute, Villejuif, France. \u201cThis approach is\nmuch more convenient for patients,\u201d he said.\u003C\/p\u003E\n\u003Cp id=\u0022p-23\u0022\u003EIn addition to treatment response, long-term outcomes were also similar in the two treatment\ngroups. Median PFS was 8.8 months in the XELOX group and 9.3 months in the FOLFOX-6 group. Median OS\nwas 19.9 months and 20.5 months in the XELOX and FOLFOX-6 arms, respectively.\u003C\/p\u003E\n\u003Cp id=\u0022p-24\u0022\u003EPatients in the XELOX and FOLFOX-6 groups reported generally similar adverse events. Among\nserious adverse events, a higher proportion of patients in the XELOX arm reported grade 3\u20134\nhand-foot syndrome (3%, vs 1% in the FOLFOX-6 arm). In contrast, more patients in the\nFOLFOX-4 arm than in the XELOX arm experienced grade 3\u20134 nausea (6% vs 3%;\np=ns), asthenia (9% vs 8%; p=ns), alopecia (4% vs 2%;\np=ns), neutropenia (47% vs 5%; p\u0026lt;0.05), febrile neutropenia (6%\nvs 0%; p\u0026lt;0.05), and neuropathy (25% vs 11%; p\u0026lt;0.05).\u003C\/p\u003E\n\u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n\u003Ch2 class=\u0022\u0022\u003EPhase 3 Trial of Capecitabine plus Oxaliplatin (XELOX) vs 5-fluorouracil (5-FU), Leucovorin,\nand Oxaliplatin (FOLFOX4) as Second-Line Treatment for Patients with Metastatic Colorectal\nCancer\u003C\/h2\u003E\n\u003Cp id=\u0022p-25\u0022\u003EThis randomized phase 3 trial was designed to establish the non-inferiority of XELOX compared\nwith FOLFOX-4 in patients with metastatic colorectal cancer who had failed first-line therapy with\nan irinotecan-based regimen.\u003C\/p\u003E\n\u003Cp id=\u0022p-26\u0022\u003EPatients were randomly assigned to treatment with XELOX (oxaliplatin 130mg\/m\u003Csup\u003E2\u003C\/sup\u003E iv,\ncapecitabine 1,000mg\/m\u003Csup\u003E2\u003C\/sup\u003E bid oral \u00d7 14 days, every three weeks) or FOLFOX-4 (as\ndescribed previously). The primary endpoint was the non-inferiority of XELOX compared with FOLFOX-4\nwith regard to progression-free survival (PFS). Secondary endpoints included overall survival (OS)\nand safety.\u003C\/p\u003E\n\u003Cp id=\u0022p-27\u0022\u003EBaseline characteristics were well balanced in the XELOX (n=314) and FOLFOX-4\n(n=313) treatment groups. The median age of patients was 61 and 60 years, respectively, and\n62% and 61% of patients were male. The distribution of baseline ECOG PS scores was\nsimilar (46\u201348% PS 0; 44\u201347% PS 1; and 7\u20138% PS 2). Primary\ntumor site, number of metastatic sites, and prior treatment history was also comparable in the XELOX\nand FOLFOX-4 arms.\u003C\/p\u003E\n\u003Cp id=\u0022p-28\u0022\u003EAdherence to treatment schedules was similar in the XELOX and FOLFOX-4 arms. Patients in the\nXELOX group received a median of 6 treatment cycles over a median of 3.9 months. Those in the\nFOLFOX-4 arm received a median of 8.5 cycles over a median of 3.9 months. Approximately one-third of\npatients in each treatment group received 24 weeks of treatment. In the XELOX arm, median relative\ndose intensities for capecitabine and oxaliplatin were 0.93 and 0.99, respectively. In the FOLFOX-4\narm, the median dose intensities reached 0.99 for both 5-FU and oxaliplatin.\u003C\/p\u003E\n\u003Cp id=\u0022p-29\u0022\u003EThe primary endpoint of this trial was met, though there were slight numerical advantages to the\nFOLFOX-4 regimen. With regard to PFS, XELOX is non-inferior to FOLFOX-4 as second-line treatment for\nmetastatic colorectal cancer. In the intent-to-treat population, median PFS was 4.7 months in the\nXELOX group and 4.8 months in the FOLFOX-4 group (HR, 0.97; 95% CI 0.83\u20131.14). Median\nOS was also similar in XELOX (11.9 months) and FOLFOX-4 (12.6 months) treatment groups (HR, 1.03;\n95% CI 0.87\u20131.23; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure\n1\u003C\/a\u003E).\u003C\/p\u003E\n\u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Secondary Endpoint: OS (ITT).\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-528585162\u0022 data-figure-caption=\u0022Secondary Endpoint: OS (ITT).\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/7\/3\/22\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11082\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n\u003Cp id=\u0022p-30\u0022 class=\u0022first-child\u0022\u003ESecondary Endpoint: OS (ITT).\u003C\/p\u003E\n\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-31\u0022\u003EThe safety profiles of XELOX and FOLFOX-4 in this trial were similar to those observed in\nprevious studies, with no unexpected toxicities. Thirty-five (35) patients experienced grade\n3\u20134 neutropenia in the FOLFOX-4 arm. By comparison, 5 patients in the XELOX arm experienced\ngrade 3 neutropenia, and no patients experienced grade 4 neutropenia. Hyperbilirubinemia was\nreported in 34% and 31% of patients in the XELOX and FOLFOX-4 groups,\nrespectively.\u003C\/p\u003E\n\u003Cp id=\u0022p-32\u0022\u003EA greater proportion of patients in the FOLFOX-4 arm (46%) than in the XELOX arm\n(38%) withdrew because of insufficient therapeutic response. However, more patients in the\nXELOX arm (20%) than in the FOLFOX-4 arm (13%) withdrew because of adverse events.\u003C\/p\u003E\n\u003Cp id=\u0022p-33\u0022\u003E\u201cThese findings demonstrate that XELOX is an effective and well-tolerated alternative to\nFOLFOX-4 as second-line therapy in metastatic colorectal cancer,\u201d Dr. Mace Rothenberg, MD,\nVanderbilt Ingram Cancer Center, Nashville, concluded.\u003C\/p\u003E\n\u003Cp id=\u0022p-34\u0022\u003EThe findings of the NO16967 trial support those from a similar study in the first-line setting\nreported at the ASCO annual meeting [Cassidy J et al. ASCO 2007. Abstract 4030].\u003C\/p\u003E\n\u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n\u003Ch2 class=\u0022\u0022\u003EUpdated Efficacy Results of the MOSAIC Trial, Including Survival, with a Median Follow-Up of\nSix Years\u003C\/h2\u003E\n\u003Cp id=\u0022p-35\u0022\u003EApproximately one million new cases of colon cancer arise each year worldwide. It has been\ndemonstrated that patients who receive leucovorin (LV)\/5-fluorouracil (5FU) after surgical resection\nof the tumor have better prognoses than those who undergo surgery alone. Recent data suggests that\noxaliplatin, in combination with LV5FU, provides an even greater survival advantage. The MOSAIC\ntrial was designed to compare the efficacy of LV5FU to LV5FU plus oxaliplatin (FOLFOX).\u003C\/p\u003E\n\u003Cp id=\u0022p-36\u0022\u003EThe primary endpoint of this study was 3-year disease free survival (DFS); these results were\npresented in 2003 and were published thereafter [Andr\u00e9 et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E\n2004]. DFS was chosen as the primary endpoint based on data published by Sargent et al. [Sargent et\nal. \u003Cem\u003EJ Clin Oncol\u003C\/em\u003E 2005] that showed that clinical trials looking at DFS can proceed\nmore rapidly, allowing more timely conclusions of treatment superiorities. Additionally, this study\nshowed that 3-year DFS correlates well with 5-year overall survival (OS). The secondary endpoints\nwere safety and OS.\u003C\/p\u003E\n\u003Cp id=\u0022p-37\u0022\u003EThe 5-year DFS in the MOSAIC study confirms the results observed after 3 years (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E) that FOLFOX is superior to LV5FU in\nthis setting. At 5 years, there was a 5.9% difference in favor of FOLFOX treatment over\nLV5FU. When stratified by disease stage, there was a 7.5% survival benefit with FOLFOX in\nstage III disease (p=0.005), while there was a non-statistically significant difference of\nonly 3.8% survival benefit with FOLFOX in stage II patients. However, high-risk stage II\npatients did appear to benefit more from FOLFOX therapy than with LV5FU (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E).\u003C\/p\u003E\n\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11087\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11087\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11087\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n\u003Cp id=\u0022p-38\u0022 class=\u0022first-child\u0022\u003EDFS in the MOSAIC Trial at 3 and 5 Years.\u003C\/p\u003E\n\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11088\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11088\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11088\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 2:\u003C\/span\u003E \n\u003Cp id=\u0022p-39\u0022 class=\u0022first-child\u0022\u003E5-Year DFS Shown By Disease Stage.\u003C\/p\u003E\n\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-40\u0022\u003EThe toxicity data, published previously [Andr\u00e9 et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2004],\nshowed two limiting toxicities with FOLFOX therapy: grade 3 and 4 neutropenia, and grade 3\nneuropathy. Long-term safety data showed that there were no differences in the development of\nsecondary cancers between the two arms. Also, there appeared to be a recovery in the degree of\nperipheral sensory neuropathy; the number of patients with grade three neuropathy decreased by about\n15% from the time of treatment out to 4 years.\u003C\/p\u003E\n\u003Cp id=\u0022p-41\u0022\u003EThe probability of surviving at 6 years was 78.6% in the FOLFOX arm and 76% in the\nLV5FU arm; these results just missed statistical significance at p=0.057. However, these\nresults were again stratified by disease type and patients with stage III disease did fare better on\nFOLFOX than on LV5FU therapy with statistical significance (p=0.029).\u003C\/p\u003E\n\u003Cp id=\u0022p-42\u0022\u003EThese results, therefore, support the use of FOLFOX as standard adjuvant therapy in colon cancer\npatients with stage III disease and possibly in patients with high-risk stage II disease. FOLFOX\ncannot, however, be recommended in low-risk stage II patients. Finally, this 5 and 6 year analysis\nsupports the idea that 3-year DFS data are predictive of overall survival.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n\u003Ch2 class=\u0022\u0022\u003EThe Impact of Dietary Patterns on Cancer Recurrence and Survival in Patients with Stage III\nColon Cancer\u003C\/h2\u003E\n\u003Cp id=\u0022p-43\u0022\u003EIn this study, Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute, Boston, examined the role\nof diet in the risk of cancer recurrence and mortality among patients with stage III colon cancer.\nThe dietary analysis was nested within a larger prospective study (CALGB 89803), which compared\npost-operative IFL and bolus 5FU\/LV in patients with stage III colon cancer.\u003C\/p\u003E\n\u003Cp id=\u0022p-44\u0022\u003ETo capture dietary patterns, patients (n=1,009) completed a food frequency questionnaire\nduring adjuvant chemotherapy treatment and 6 months after. Two major dietary patterns were\nidentified. The Western pattern diet was characterized by a higher intake of red meat, fat, refined\ngrains, and desserts. The prudent pattern diet was characterized by higher intake of fruits,\nvegetables, poultry, and fish.\u003C\/p\u003E\n\u003Cp id=\u0022p-45\u0022\u003EIn the primary analysis of the CALGB 89803 trial, there was no difference in efficacy between the\ntwo chemotherapy regimens. Therefore, data from all patients was pooled for the dietary analysis.\nPatients were evaluated according to quintiles of each dietary pattern and followed for cancer\nrecurrence or death.\u003C\/p\u003E\n\u003Cp id=\u0022p-46\u0022\u003EThe median follow-up was 5.3 years. Patient data was adjusted for gender, age, T and N stage,\nbody mass index (BMI), physical activity level, weight change, baseline performance status, and\nadjuvant chemotherapy treatment arm.\u003C\/p\u003E\n\u003Cp id=\u0022p-47\u0022\u003EAmong patients who followed the Western pattern diet, those in the higher quartiles were more\nlikely to be male (p\u0026lt;0.0001) and more likely to smoke (p\u0026lt;0.0001). Other baseline\ncharacteristics, including age, BMI, level of physical activity, and disease characteristics were\nsimilar across quintiles.\u003C\/p\u003E\n\u003Cp id=\u0022p-48\u0022\u003EPatients who were more likely to follow a Western pattern diet after diagnosis with stage III\ncolon cancer had a poorer long-term outcome, with triple the risk for cancer recurrence or death.\nCompared to those in the lowest quintile of Western pattern diet intake, those in the highest\nquintile had a lower disease-free survival (DFS; HR, 3.91; p\u0026lt;0.0001), recurrence-free\nsurvival (RFS; HR, 3.14; p\u0026lt;0.0001), and overall survival (OS; HR, 3.75; p\u0026lt;0.0001;\n\u003Ca id=\u0022xref-table-wrap-3-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T3\u0022\u003ETable 1\u003C\/a\u003E). This pattern was consistent\nregardless of age, BMI, gender, physical activity level, or treatment arm.\u003C\/p\u003E\n\u003Cdiv id=\u0022T3\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/11094\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/11094\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11094\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1:\u003C\/span\u003E \n\u003Cp id=\u0022p-49\u0022 class=\u0022first-child\u0022\u003EImpact of Western and Prudent Pattern Diets on Colon Cancer Recurrence and Mortality.\u003C\/p\u003E\n\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n\u003Cp id=\u0022p-50\u0022\u003EPrudent pattern diet did not significantly influence long-term outcome. Patients in the lowest\nand highest quintiles of prudent pattern diets had similar risk for DFS, RFS, and OS.\u003C\/p\u003E\n\u003Cp id=\u0022p-51\u0022\u003EThough this trial confirms a link between diet and prognosis, the mechanism driving the\nassociation is unclear. For example, smokers and those who adhere to Western diets may develop\ntumors with a distinct phenotype that worsens prognosis. Behaviors after diagnosis may not\nnecessarily make the difference in outcome.\u003C\/p\u003E\n\u003Cp id=\u0022p-52\u0022\u003EDeborah Schrag, MD, Memorial Sloan-Kettering Cancer Center, New York, said that the results of\nthis study should change practice. \u201cWe need to incorporate diet and exercise recommendations\ninto post-treatment counseling,\u201d she said. \u201cThe challenge is to develop educational\ntools to teach our patients about diet and exercise, and to help motivate them,\u201d she\nconcluded.\u003C\/p\u003E\n\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2007 MD Conference Express\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/7\/3\/22.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzma8e\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzma8e\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_tables.js?nzma8e\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}