Management of patients with early-stage colon cancer: guidelines of the Italian Medical Oncology Association

About 75% of colorectal cancers are diagnosed as early stage, in which radical surgery is achievable. In the last decade, in Italy, the overall incidence of colorectal cancer has remained stable, while mortality gradually decreased, which is attributable to early diagnosis and improved medical, surgical and locoregional treatments. The Italian Medical Oncology Association formulated guidelines to manage early-stage colon cancer, including screening, diagnosis, treatment and follow-up, which we herein present.

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Weekly Fluorouracil and Leucovorin as Adjuvant Therapy for Early Stage Colon Cancer or Primary Therapy for Advanced Colorectal Cancer

Hospital Pharmacy ◽

10.1177/001857870103600302 ◽

2001 ◽

Vol 36 (3) ◽

pp. 243-249

Author(s):

J. Aubrey Waddell ◽

Dominic A. Solimando

Keyword(s):

Colorectal Cancer ◽

Colon Cancer ◽

Adjuvant Therapy ◽

Cancer Chemotherapy ◽

Advanced Colorectal Cancer ◽

Early Stage ◽

Primary Therapy ◽

Toxic Agents ◽

Early Stage Colon Cancer

The increasing complexity of cancer chemotherapy makes it mandatory that pharmacists be familiar with these highly toxic agents. This column reviews various issues related to the preparation, dispensing, and administration of cancer chemotherapy, both commercially available and investigational.

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Comparative clinical efficacy of adjuvant chemotherapy regimens in randomized controlled trials (RCTs) of early-stage colon cancer: Systematic review and meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.4_suppl.498 ◽

2011 ◽

Vol 29 (4_suppl) ◽

pp. 498-498

Author(s):

J. Cassidy ◽

H. Schmoll ◽

E. Chu ◽

N. Hawkins ◽

I. Tatt ◽

...

Keyword(s):

Systematic Review ◽

Colon Cancer ◽

Adjuvant Chemotherapy ◽

Assessment Tool ◽

Early Stage ◽

Meta Analysis ◽

Group Analysis ◽

Significant Difference ◽

Early Stage Colon Cancer

498 Background: A systematic review was conducted to identify RCTs of adjuvant chemotherapy regimens for early-stage colon cancer and a network meta-analysis performed to compare efficacy of oxaliplatin/fluoropyrimidine regimens. Methods: A systematic review identified RCTs recruiting adult patients with early-stage (adjuvant) stage II/III colon cancer. Outcome measures included hazard ratios for DFS and OS. Only publications in English were considered. Study quality was assessed using the Cochrane Collaboration “risk of bias” assessment tool. A single reviewer screened abstracts/titles using predefined selection criteria, with critical appraisal and data extraction conducted independently by two reviewers. A Bayesian network meta-analysis was used to estimate comparative efficacy of adjuvant chemotherapy across RCTs. Results: 56 articles describing 40 trials were selected, of which six reported data on regimens accepted as current standard of care (capecitabine/X-ACT, XELOX/NO16968, FOLFOX/MOSAIC, FLOX/C-07) or common comparators: bolus 5FU/LV and LV5FU2 (C-96-1, PETACC-2). Statistical assessment of heterogeneity was not possible due to the limited study network. Baseline characteristics were similar across trials with the exception of three trials recruiting only stage III patients; sub-group analysis on these trials was not possible due to lack of common comparators. There was no significant difference in DFS at a median follow-up of 3-years (or closest reported analysis) for XELOX vs. FLOX (HR=0.99, 95% CI 0.80–1.22) or FOLFOX (HR=1.00, 95% CI 0.72–1.41). There was also no significant difference in OS at a median follow-up of at least 5 years. Taken as a class, oxaliplatin-containing regimens (XELOX, FOLFOX, FLOX) improved DFS vs. non-oxaliplatin-containing regimens (HR=0.80, 95% CI 0.73–0.87). This result was confirmed for OS. Conclusions: Despite the limited number of available trials, the results of these analyses demonstrate a clear benefit of incorporating oxaliplatin into combination regimens for early-stage colon cancer. XELOX, FOLFOX and FLOX appear to be equivalent in terms of efficacy in this setting. [Table: see text]

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Caution Is Required Before Recommending Routine Carcinoembryonic Antigen and Imaging Follow-Up for Patients With Early-Stage Colon Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2009.25.6156 ◽

2009 ◽

Vol 27 (36) ◽

pp. e279-e280 ◽

Cited By ~ 21

Author(s):

Michael Chao ◽

Peter Gibbs

Keyword(s):

Colon Cancer ◽

Carcinoembryonic Antigen ◽

Early Stage ◽

Early Stage Colon Cancer

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Capecitabine in early-stage colon cancer and metastatic colorectal cancer: Results from an Austrian noninterventional trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14103 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14103-e14103

Author(s):

Wolfgang Eisterer ◽

Bjoern Jagdt ◽

Christa Haeusler ◽

Markus Krenn

Keyword(s):

Colorectal Cancer ◽

Colon Cancer ◽

Clinical Practice ◽

Adjuvant Therapy ◽

Metastatic Colorectal Cancer ◽

Treatment Duration ◽

Early Stage ◽

Routine Clinical Practice ◽

Line Therapy ◽

Early Stage Colon Cancer

e14103 Background: Capecitabine (Cap) is approved for adjuvant therapy in stage III colon cancer and for metastatic colorectal cancer (mCRC) in Austria. Methods: In this open-label, multicenter, single-arm non-interventional trial, Cap-based therapy in patients with early-stage colon cancer and mCRC was observed at 30 sites. Cap was prescribed at the physician’s discretion and according to drug labelling. 409 patients were included between 2008 and 2011. Safety of Cap in routine clinical practice was the primary study endpoint. All adverse events (AEs) were documented in an online CRF by participating investigators. Progression-free survival (PFS), defined as the time from study entry until tumour progression or death, and treatment duration were also assessed. Results: Most of the 409 patients were ≥65 years old (72.6%; n=297). 249 (60.9%) patients were male and 160 (39.1%) were female. 221 (54.0%) patients received Cap as adjuvant therapy; 111 (50.2%) of these received Cap alone, and 110 (49.8%) were treated with Cap plus oxaliplatin. 188 (46.0%) patients were treated for mCRC; 105 (55.9%) received first-line therapy, 48 (25.5%) second-line therapy and 35 (18.6%) third-line or later lines of therapy with different Cap-containing regimens. 163 mCRC patients were eligible for PFS evaluation. The median PFS was 8.1 (range 1.0–28.5) months. Patients who received Cap-based therapy for at least 8 cycles (n=97) had a profound increase in PFS to 9.4 months. The longest treatment duration with Cap was 47 cycles. The median duration of treatment for all patients was 8 cycles (range 1–47) at a median daily dose of 1944 mg/m2 (range 833–3055 mg/m²) for Cap alone and 1862 mg/m2 (range 1111–4166 mg/m²) as part of a combination regimen. The most common grade 3/4 AEs included diarrhoea (2.2%), hand-foot syndrome (2.0%), nausea (0.7%), neuropathy (0.7%), and leukopenia (0.2%). Conclusions: Cap therapy is well tolerated in routine clinical practice. The median number of 8 cycles correlates well with the suggested treatment duration. AEs included only known and previously documented safety reactions. Prolonged treatment with Cap in patients with mCRC leads to a meaningful increase in PFS.

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Global clinical experience with adjuvant oxaliplatin/5-fluorouracil (5-FU)-based chemotherapy for colon cancer: Outcomes of the ACCElox registry.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e14624 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e14624-e14624

Author(s):

Young Suk Park ◽

Jiafu Ji ◽

John Raymond Zalcberg ◽

Mostafa M. Elserafy ◽

Antonio C. Buzaid

Keyword(s):

Colon Cancer ◽

Clinical Practice ◽

Early Stage ◽

Sensory Neuropathy ◽

Post Treatment ◽

Stage Ii ◽

Early Stage Colon Cancer ◽

Stage Ii Colon Cancer ◽

Practice Methods

e14624 Background: The ACCElox registry assessed the therapeutic management of early stage colon cancer with oxaliplatin/5-FU-based regimen and duration of adjuvant chemotherapy in current clinical practice. Methods: Newly diagnosed patients (N=1,548) with stage II or III colon cancer, who had undergone complete resection of the primary tumor and treated with at least one dose of "oxaliplatin" were enrolled in this prospective observational study (Feb-2006–Jul-2008) and followed up till 36 months post-treatment. Results: 72.7% and 27.3% of the patients were diagnosed with stage III and stage II colon cancer, respectively. 1,152 (74.4%) patients completed the prescribed chemotherapy. The most frequent causes of discontinuation were refusal (9.0%), adverse events (AEs) (8.1%) or relapse/recurrence of disease (3.6%). Overall, 1,512 (97.6%) patients received at least one cycle of oxaliplatin regimen. Treatment delay occurred in 1,013 patients (67%), mainly attributed to AEs (40.9%) and personal inconvenience (35.5%). During the 3-year follow-up period disease relapse/recurrence occurred in 285 (18.4%) patients with similar rates in the three groups (FOLFOX: 18.1%, FLOX: 19%, and XELOX: 18.6%). Overall number of deaths reported at the end of 3- year study period was 72 (4.7%). Majority of AEs reported during treatment were of grade 1–2 and the most common ones were neutropenia (63.9%), thrombocytopenia (23.3%), diarrhea (9.7%), sensory neuropathy (4.5%) and infection (2.6%). Sensory neuropathy was the most frequent AEs reported at 6 and 12 months of post-treatment follow-up. Conclusions: A majority of the patients completed the prescribed oxaliplatin/5-FU regimen. No unexpected AEs were reported. Our results confirm the favorable benefit/risk profile of oxaliplatin/5-FU based regimens in clinical practice. [caption]Distribution and treatment outcomes.[caption] Clinical trial information: NCT01310972. [Table: see text]

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Clinicopathological Features of Stage I–III Colorectal Cancer Recurrence Over 5 Years After Radical Surgery Without Receiving Neoadjuvant Therapy: Evidence From a Large Sample Study

Frontiers in Surgery ◽

10.3389/fsurg.2021.666400 ◽

2021 ◽

Vol 8 ◽

Author(s):

Dakui Luo ◽

Yufei Yang ◽

Zezhi Shan ◽

Qi Liu ◽

Sanjun Cai ◽

...

Keyword(s):

Colorectal Cancer ◽

Neoadjuvant Therapy ◽

Radical Surgery ◽

Early Stage ◽

Multivariate Logistic Regression Analysis ◽

Late Recurrence ◽

Signet Ring Cell ◽

Stage I ◽

Cancer Center

Late recurrence (5 or more years) after radical resection of colorectal cancer (CRC) is rare. This study aims to investigate the features of late recurrence in stage I–III CRC. A total of 9,754 stage I–III patients with CRC who underwent radical surgery without receiving neoadjuvant therapy, at the Fudan University Shanghai Cancer Center (FUSCC), were enrolled in this study. These patients were divided into three groups: early recurrence (3 months−2 years), intermediate recurrence (2–5 years), and late recurrence (over 5 years). The median duration of follow-up was 53.5 ± 30.1 months. A total of 2,341 (24.0%) patients developed recurrence. The late recurrence rate was 11.7%. Patients with a higher risk of late recurrence were more likely to be older, to be at the T4 stage, to have a higher degree of colon cancer, to have a lower frequency of signet ring cell carcinoma, to have fewer poorly differentiated tumors, to be at the early stage of CRC, along with less perineural and vascular invasions. Multivariate logistic regression analysis identified age, differentiation, T stage, N stage, perineural, and vascular invasions as independent factors for late recurrence. Late recurrent CRC has some distinctive characteristics. Although recurrence over 5 years after surgery is infrequent, an enhanced follow-up is still needed for the selected patients after 5 years.

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