Research supports less chemotherapy after bowel cancer surgery

NIHR | June 2018 | Research supports less chemotherapy after bowel cancer surgery

New research funded by the NIHR shows that patients with bowel cancer may only need half of the number of sessions of chemotherapy than they currently receive. The international clinical research trial indicates that people with bowel cancer who are currently given 6 months of chemotherapy may only need three months of treatment (Source: NIHR).
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The full story is available at NIHR 

Background

6 months of oxaliplatin-containing chemotherapy is usually given as adjuvant treatment for stage 3 colorectal cancer. We investigated whether 3 months of oxaliplatin-containing chemotherapy would be non-inferior to the usual 6 months of treatment.

Methods

The SCOT study was an international, randomised, phase 3, non-inferiority trial done at 244 centres. Patients aged 18 years or older with high-risk stage II and stage III colorectal cancer underwent central randomisation with minimisation for centre, choice of regimen, sex, disease site, N stage, T stage, and the starting dose of capecitabine. Patients were assigned (1:1) to receive 3 months or 6 months of adjuvant oxaliplatin-containing chemotherapy. The chemotherapy regimens could consist of CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin). The regimen was selected before randomisation in accordance with choices of the patient and treating physician. The primary study endpoint was disease-free survival and the non-inferiority margin was a hazard ratio of 1·13. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who started study treatment. This trial is registered with ISRCTN, number ISRCTN59757862, and follow-up is continuing.

Findings

6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013. The intended treatment was FOLFOX in 1981 patients and CAPOX in 4107 patients. 3044 patients were assigned to 3 month group and 3044 were assigned to 6 month group. Nine patients in the 3 month group and 14 patients in the 6 month group did not consent for their data to be used, leaving 3035 patients in the 3 month group and 3030 patients in the 6 month group for the intention-to-treat analyses. At the cutoff date for analysis, there had been 1482 disease-free survival events, with 740 in the 3 month group and 742 in the 6 month group. 3 year disease-free survival was 76·7%  for the 3 month group and 77·1%  for the 6 month group, giving a hazard ratio of 1·006 (0·909–1·114, test for non-inferiority p=0·012), significantly below the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was more common in the 6 month group (237 [58%] of 409 patients for the subset with safety data) than in the 3 month group (103 [25%] of 420) and was long-lasting and associated with worse quality of life. 1098 serious adverse events were reported (492 reports in the 3 month group and 606 reports in the 6 month group) and 32 treatment-related deaths occurred (16 in each group).

Interpretation

In the whole study population, 3 months of oxaliplatin-containing adjuvant chemotherapy was non-inferior to 6 months of the same therapy for patients with high-risk stage II and stage III colorectal cancer and was associated with reduced toxicity and improved quality of life. Despite the fact the study was underpowered, these data suggest that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care.

The findings have now been published in the journal Lancet Oncology where the article can now be downloaded

Full reference:

Iveson, Timothy J et al.| 2018| 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial|The Lancet Oncology | Vol. 19| Issue 4| P.  562 – 578

Three-month course of chemotherapy as effective as six months following surgery for bowel cancer

NIHR   | March 2018  |Three-month course of chemotherapy as effective as six months following surgery for bowel cancer

NIHR and MRC in partnership  have funded international clinical trial, which has evaluated the effectiveness of a three-month course of adjuvant oxaliplatin/fluoropyrimidine combination chemotherapy for colorectal cancer versus the standard six-month treatment regimen. The trial’s findings indicate that the shorter duration treatment leads to similar survival outcomes with better quality of life for patients and therefore might represent a new standard of care.

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The research team led by the Cancer Research UK Clinical Trials Unit in Glasgow, recruited more than  6,000 patients with high-risk stage II or stage III colorectal cancer from 244 centres across Europe, Australia and New Zealand. The participants in the trial  received either a three or six month course of chemotherapy and were followed up for a minimum of three years.

Three years later, 76.7% of patients who received treatment over three months were disease free compared to 77.1% of patients treated over six months. Patients treated over three months had fewer side effects and reported a better quality of life as well as reduced peripheral neuropathy.

Chief Investigator Dr Tim Iveson, Consultant Medical Oncologist at University Hospital Southampton NHS Foundation Trust and Honorary Associate Professor at the University of Southampton, said: “Bowel cancer is the fourth most common cancer in the UK with 41,000 new cases each year. Bowel cancer can be cured by surgery and chemotherapy. Approximately 2,500 patients per year currently receive up to six months of post-operative chemotherapy. Reducing chemotherapy duration to three months will save the NHS £5000 per patient – a total saving to the NHS of £12.5 million pounds per year.

Dr Iveson added: “The impact on patients is important, as by having a shorter course of chemotherapy patients have fewer side effects.  Based on these results, three months of post-operative chemotherapy should be considered as the new standard care for many patients with bowel cancer.”

The full unedited news item is available from NIHR  here

Summary

Background

6 months of oxaliplatin-containing chemotherapy is usually given as adjuvant treatment for stage 3 colorectal cancer. We investigated whether 3 months of oxaliplatin-containing chemotherapy would be non-inferior to the usual 6 months of treatment.

Methods

The SCOT study was an international, randomised, phase 3, non-inferiority trial done at 244 centres. Patients aged 18 years or older with high-risk stage II and stage III colorectal cancer underwent central randomisation with minimisation for centre, choice of regimen, sex, disease site, N stage, T stage, and the starting dose of capecitabine. Patients were assigned (1:1) to receive 3 months or 6 months of adjuvant oxaliplatin-containing chemotherapy. The chemotherapy regimens could consist of CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin). The regimen was selected before randomisation in accordance with choices of the patient and treating physician. The primary study endpoint was disease-free survival and the non-inferiority margin was a hazard ratio of 1·13. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who started study treatment. This trial is registered with ISRCTN, number ISRCTN59757862, and follow-up is continuing.

Findings

6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013. The intended treatment was FOLFOX in 1981 patients and CAPOX in 4107 patients. 3044 patients were assigned to 3 month group and 3044 were assigned to 6 month group. Nine patients in the 3 month group and 14 patients in the 6 month group did not consent for their data to be used, leaving 3035 patients in the 3 month group and 3030 patients in the 6 month group for the intention-to-treat analyses. At the cutoff date for analysis, there had been 1482 disease-free survival events, with 740 in the 3 month group and 742 in the 6 month group. 3 year disease-free survival was 76·7% (95% CI 75·1–78·2) for the 3 month group and 77·1% (75·6–78·6) for the 6 month group, giving a hazard ratio of 1·006 (0·909–1·114, test for non-inferiority p equal to 0·012), significantly below the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was more common in the 6 month group (237 [58%] of 409 patients for the subset with safety data) than in the 3 month group (103 [25%] of 420) and was long-lasting and associated with worse quality of life. 1098 serious adverse events were reported (492 reports in the 3 month group and 606 reports in the 6 month group) and 32 treatment-related deaths occurred (16 in each group).

Interpretation

In the whole study population, 3 months of oxaliplatin-containing adjuvant chemotherapy was non-inferior to 6 months of the same therapy for patients with high-risk stage II and stage III colorectal cancer and was associated with reduced toxicity and improved quality of life. Despite the fact the study was underpowered, these data suggest that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care.

Funding

Medical Research Council, Swedish Cancer Society, NETSCC, and Cancer Research UK.

 

Full reference:
Iveson, T. J., et al  |    2018  | 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial The Lancet Oncology  |  Vol. 19  | 4 | P.562–78

The full article can be read in The Lancet here

New chemotherapy approach offers breast cancer patients a better quality of life

The chemotherapy drug capecitabine gives patients a better quality of life and is as effective at preventing breast cancer from returning as the alternative regimen called CMF, when given following epirubicin. | ScienceDaily | Cancer Research UK

Around 4,400 patients on the TACT2 clinical trial were treated with the chemotherapy drug epirubicin followed by either capecitabine or CMF, after surgery.

Researchers at The Institute of Cancer Research, London, and the Cancer Research UK Edinburgh Centre found that capecitabine resulted in patients experiencing fewer side effects and having a better quality of life, and it was as effective at preventing cancer’s return as CMF.

Most patients experienced some side effects regardless of the treatment they were given. But those taking CMF were more likely to experience severe side effects including early menopause, nausea, infection, thrombosis, and anemia.

During the trial, patients were followed up after 12, 18 and 24 months, and then yearly for at least 10 years, to see if their cancer had returned and to monitor side effects. More than 85 per cent of patients did not experience their cancer returning for at least five years.

More detail at

Link to the research:

Cameron, D., et al.  Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. The Lancet Oncology.

Breast cancer e-support program vs routine care

Zhu, J. et al. (2017) BMC Cancer. 17:291

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Background: Women with breast cancer undergoing chemotherapy suffer from a number of symptoms and report receiving inadequate support from health care professionals. Innovative and easily accessible interventions are lacking. Breast Cancer e-Support is a mobile Application program (App) that provides patients with individually tailored information and a support group of peers and health care professionals. Breast Cancer e-Support aims to promote women’s self-efficacy, social support and symptom management, thus improving their quality of life and psychological well-being.

Discussion: This is the first study of its kind in China to evaluate the use of a mobile application intervention with a rigorous research design and theoretical framework. This study will contribute to evidence regarding the effectiveness of a theory-based mobile application to support women with breast cancer undergoing chemotherapy. The results should provide a better understanding of the role of self-efficacy and social support in reducing symptom distress and of the credibility of using a theoretical framework to develop internet-based interventions. The results will provide evidence to support the implementation of an innovative and easily accessible intervention that enhances health outcomes.

Read the full protocol here

Measuring patients’ muscles to predict chemotherapy side effects

Measuring patients’ muscle mass and quality could potentially help doctors better identify patients at high risk for toxic side effects that could require hospitalizations, researchers report | ScienceDaily

Researchers at the University of North Carolina Lineberger Comprehensive Cancer Center report in the journal Clinical Cancer Research that a tool developed at UNC could potentially help doctors better identify patients at high risk for toxic side effects that could require hospitalizations.

Shlomit Strulov Shachar, MD, the study’s first author, said they found that low measures of muscle quality and quantity in patients with early-stage breast cancer were linked to serious side effects and hospitalizations. Based on their findings, the researchers believe measuring muscle composition could be helpful in predicting which patients will experience side effects from chemotherapy, and in determining appropriate drug doses.

Read the full overview here

Read the original research abstract here

Prevalence of cancer chemotherapy-related problems and associated supportive care

Wagland, R. et al. (2016) Supportive Care in Cancer. 24(12) pp. 4901–4911

Purpose: The purpose of this study was to identify the treatment-associated problems that most impact on patients undergoing cancer chemotherapy, how problems relate to experiences of supportive care and variations in experience between cancer treatment centres.

Conclusion: The most common and distressing chemotherapy-associated problems were identified. These problems are mitigated by quality supportive care. Routine measurement and monitoring of problem items and supportive care are warranted to facilitate benchmarking and service improvements both within and between cancer centres.

Read the full abstract here

Cost-effectiveness research in cancer therapy

Al-Badriyeh, D. et al. (2017) BMJ Open, 7:e012648

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Objective: To perform a first-time analysis of the cost-effectiveness (CE) literature on chemotherapies, of all types, in cancer, in terms of trends and change over time, including the influence of industry funding.

Conclusions: This analysis demonstrates clear trends in how the CE cancer research is presented to the practicing community, including in relation to journals, study designs, authorship and consultation, together with increased financial sponsorship by pharmaceutical industries, which may be more influencing study outcomes than other funding sources.

Read the full systematic review here