North of Scotland Cancer Network Clinical Management Guideline for Colorectal Cancer

Transcription

1 rth of Scotland Cancer Network Clinical Management Guideline for Colorectal Cancer Based on WOSCAN CRC CMG with further extensive consultation within NOSCAN Document Control Prepared by N.McLachlan NOSCAN CRC MCN Manager Approved by NOSCAN CRC MCN [September 2012] Issue date October 2012 Review date October 2013 Version v1.0 1

2 Colon Cancer Evaluation Primary Treatment Adjuvant Treatment Adenocarcinoma of colon Hx and Physical Examination Examination of colon which will remain after surgical resection and biopsy of any lesions outwith the proposed resection CT Chest/Abdo/Pelvis Baseline CEA (a) Primary Resectable? Potentially curative resection? Consider neoadjuvant chemotherapy Resection Obstructing Consider bridging stent/ straight to surgery Stage I (Dukes A) Stage II low risk (Dukes B) Surveillance (a) Though evidence to support routine surveillance monitoring is limited, a baseline pre-operative CEA assessment should be considered. n-curative resection? Stage II high risk (b) (b) Factors taken into consideration include patient fitness, LN number, pt4 disease, tumour perforation, vascular/perineural invasion, margin involvement and differentiation. Scoring systems may aid decision making, and for some select node -ve pts with presence of above, adjuvant chemo may also be considered appropriate (c) Choice of chemotherapy Performance status Co morbidities Life expectancy Consider Raltitrexed if significant cardiac history. Stoma / stent if obstructed Palliative Chemotherapy/ Radiotherapy/Other Stage III (Dukes C) Fit for Chemo adequate FBC, U&Es LFTs, CrCl >30, PS>60% Capecitabine or infusional 5FU +/- Oxaliplatin (c) te: If available, clinical trials should always be considered as the preferred option for eligible patients 2

3 Rectal Cancer MDT Evaluation Primary Treatment Adjuvant Treatment Rectal adenocarcinoma ( 15cm from Anal verge) Small low rectal tumours Favourable histology Consideration should be given to referring all such patients to units/surgeons who do ERUS and TEMS pt1 pt2 Unfavourable Histology Surveillance (f) Consider (chemo) RT History & exam Digital exam Biopsy Path. review CT C/A/P Thin-slice MRI pelvis Full assessment of remaining colon Risk of Margin Involvement? Low risk of involved margins Unfavourable Histology (d) Consider Short-Course RT Formal resection Surgery (+/- radiotherapy) R0, LN - low risk (a) Surveillance R0, LN - high risk (a) R0 LN + If no previous RT Adjuvant chemo Capecitabine or Infusional 5FU/FA +/- Oxaliplatin (b) (d) Unfavourable Histology Poor differentiation Lymphovascular/ perineural invasion High/known risk of involved margins (e) (e) Margin threat Determined in MDT meeting : Clinical fixity / Radiological features suggesting R0 resection unlikely. Tumour encroachment / breach of meso-rectal fascia; T2 at or below levator origin Chemoradiation/ Radiotherapy (g) (f) pt2 disease Decision re TART + CRT versus formal resection to be determined on an individual basis R+ ChemoRT & Surgery Adjuvant chemort Capecitabine or Infusional 5FU/FA +/- +/- Oxaliplatin(b) Adjuvant Chemo can be considered (b) (g) Chemoradiation optimal, but may only be fit for radiotherapy te: If available, clinical trials should always be considered as the preferred option for eligible patients 3

4 Metastatic Colorectal Cancer Evaluation Treatment Stage IV with metastatic confirmation Resectable Lung or liver lesions and Resectable primary n-resectable rectal primary + resectable Liver/lung disease Synchronous resection of metastases and primary tumour if delay in resection of metastases consider chemo prior to resection Oxaliplatin or capecitabine +5FU/FA plus chemoradiation Pathology review CT chest abdomen pelvis MRI of pelvis for rectal cancer +/- PET scan (h) Unresectable liver only metastases (i) Unresectable lung or liver lesions (h) KRAS testing Mutant Wildtype Capecitabine or infusional 5FU/FA + / - Oxaliplatin(b) Limited colonic resection/bypass or stent if patient has impending obstruction Palliative care Cetuximab + OxMdG or IrinotecanMdG if a downstaging curative resection is possible Following Treatment Resectable? Ye s Consider resection of primary tumour and metastases (sequentially or synchronously in suitable patients) Individualised treatment and follow-up Amenable to RFA +/- surgery? Individualised treatment and follow-up (h) Only consider PET for potentially resectable patients and/or where possible as part of a trial Second-line chemotherapy (Irinotecan and 5FU/FA) Clinical Trial Palliative Care (i) All liver only metastases to be discussed with a liver surgeon (and primary surgeon) at MDT te: If available, clinical trials should always be considered as the preferred option for eligible patients 4

5 Evaluation Negative PET scan Consider repeat Investigations 3 months Clinical Management Guideline for Colorectal Cancer Follow up Negative Treatment Individualised surveillance If recurrence Liver and/or Lung only, refer to relevant surgical team Positive If recurrence is peritoneal; or pelvic for rectal cancer, consider referral to specialist surgical unit Pre-op ChemoRT if pelvic recurrence Resection of recurrence, + / - chemotherapy CT chest, abdo, pelvis Clinical exam MRI pelvis Positive Is Recurrence potentially resectable? 1 st line Chemotherapy (see page 3) Palliative Care Following treatment Is recurrence resectable? Resection of Recurrent lesions Elevated CEA (a) Positive monitoring exam Symptoms Is recurrence amenable to RFA +/- surgery? 2 nd line chemotherapy (see page 3) Phase I trial Palliative Care RFA+/- surgery Individualised treatment/ monitoring considering response te: If available, clinic trials should always be considered as the preferred option for eligible patients 5

6 Colorectal Cancer Follow up Patient indicates their wish to be actively followed up? High Risk of disease relapse? Potentially suitable for future Surgical Resection if becomes required? Primary Treatment completed Patient fit for further active intervention in event of recurrence? Low Risk of Disease relapse? Intensive follow-up schedule Potentially suitable for future Chemotherapy/RT if becomes required? Has patient any symptoms requiring palliation? n-intensive follow-up schedule Refer to Palliative Care Discharge to Primary Care /GP te: If available, clinic trials should always be considered as the preferred option for eligible patients 6

7 Colorectal Cancer Follow up OBSERVATIONS / SURVEILLANCE The follow-up recommendations apply with the following caveats: 1. The patient has indicated their understanding of anticipated reasons/benefits/risks and indicated their agreement 2. The patient is/remains fit for further intervention 3. That the colon is fully imaged around or shortly after surgery. 4. There is no evidence of an underlying genetic condition (HNPCC etc). 5. There is no evidence of synchronous polyps. History/ examination/cea (a) at 6 monthly intervals for first 2 years Exit review at end year 3 Intensive follow up n-intensive follow up Annual CT x 3 years with alternating 6 monthly imaging by ultrasound/ct. Colonoscopy within 6 months only if colon evaluation pre-op was incomplete. If adenomas were present at diagnosis of cancer, colonoscopy follow-up according to adenoma protocol If no adenomas were present, repeat colonoscopy 5 yearly until risk outweighs benefit History/ examination/cea (a) at 6 months Then annual follow-up for 3 years Colonoscopy within 6 months only if colon evaluation pre-op was incomplete. If adenomas were present at diagnosis of cancer, colonoscopy follow-up according to adenoma protocol If no adenomas were present, repeat colonoscopy 5 yearly until risk outweighs benefit. In patients considered either clinically unfit/ unsuitable, or who have indicated their wish not to pursue further active intervention in event of disease relapse: Single post treatment review only and discharge to GP/other speciality as appropriate and if required. Other follow up where local resources available and permit te: If available, clinic trials should always be considered as the preferred option for eligible patients 7

8 Malignant Colorectal Polyps In view of there being no authoritative consensus having been reached, and in view of the clinical evidence available continuing to evolve, the MCN recommendation is that all such cases should be individually discussed at the MDT and taking account of latest best evidence. te: If available, clinic trials should always be considered as the preferred option for eligible patients 8

9 NOSCAN Clinical Management Guideline for Colorectal Cancer: Glossary of terms used (1) Abdo C/A/P CEA CT CRT Dukes ERUS FA FBC HNPCC Hx KRAS LN MDT MRI OxMdG Abdomen Chest, Abdomen, and Pelvis as in areas of body to be included in a radiological examination ie CT of C/A/P Carcino-embryonic antigen - a glycoprotein involved in cell adhesion, it is normally produced during foetal development but may also be elevated in the bloodstream of patients who are known to have certain cancers. In such cases it can be used as an early indicator of disease presence or recurrence after surgery. However can be raised for non cancer reasons. Computed Tomography - an imaging method that uses x-rays to create cross-sectional pictures (or slices ) of the body. Chemo-radiotherapy or Chemo-radiation when radiotherapy is given at the same time as a patient is also receiving chemotherapy Refers to the classification system for colorectal cancer which was devised originally by the British pathologist Cuthbert Dukes ( ) and relates to the extent of disease spread or invasion on pathological examination ie Dukes A, B or C. It is now clinically superseded by the American TNM system, which is considered to be more detailed. Endoscopic Rectal Ultrasound a type of diagnostic test using an endoscope incorporating an ultrasound probe to provide more detailed imaging of the rectal wall and specifically the layers of the bowel wall. Folinic Acid - a drug which is usually given in combination with 5-Fluorouracil (as in 5-FU/FA ) to enhance efficacy of chemotherapy Full Blood Count a type of blood test (which measures the ratios of different red or white cells in a blood sample) Hereditary n-polyposis Colorectal Cancer - a rare condition that runs in families and which is the most common cause of hereditary bowel cancer Medical History a brief narrative or history of a persons previous illnesses or medical procedures Kirsten rat sarcoma - a particular type of cancer cell sub-type Lymph des small bean-shaped lymph glands or 'nodes' which filter the lymph fluid as it passes through the lymphatic (or the bodies drainage) system. Multi-Disciplinary Team an arrangement whereby individuals with different clinical expertise work collaboratively to agree the most appropriate treatment for a patient Magnetic Resonance Imaging a type of radiological imaging that uses changes in the bodies magnetic fields to build up an image of the internal human structures. Oxaliplatin and Modified de Gramont a type of chemotherapy regimen (which is a combination of Oxaliplatin and 5-Fluoracil with Folinic Acid) which is used to treat colon and rectal cancer. The drugs are customarily infused into a peripheral vein (or via a central line) over a prolonged period of time (usually 48hrs 9

10 NOSCAN Clinical Management Guideline for Colorectal Cancer: Glossary of terms used (2) PET PS R0 RFA RT Stent TART TEMS T- Stage U&Es +ve with or without as in +/- +/- -ve 5FU Positive Emission Tomography where a special form of computed tomography is used to detect areas of increased metabolic activity in the human body (as indicated by areas where a previously ingested radio sensitive sugar solution is being more concentrated) Performance Status as in a scale of general wellness or how fit someone is perceived to be able to withstand a proposed clinical treatment Removal of all local tumour to the naked eye and also with clear margins under the microscope Radio Frequency Ablation the use of very high frequency and short wave radio signals (or micro-waves) to destroy body tissue or cancer cells Radio Therapy - the use of high energy waves or X-Rays to destroy body tissue or cancer cells A tube (usually of metal mesh) that is inserted into a tubular body structure (such as the colon or rectum) in order to permit the continued passage of contents through. Trans-anal Resection of Tumour a surgical technique whereby diseased tissue of the rectum is removed via the anal canal rather than making an external anatomical excision Trans-anal Endoscopic Microsurgery a surgical technique whereby diseased tissue is removed from the rectum via an instrument inserted into the anal canal and which utilises a special microscope Tumour stage (as in T2 or T3) and based on the American TNM system used to measure the local depth of spread of cancer into / through the bowel wall Urea & Electrolytes a type of blood test which measures the levels of different salts and bi-products in the bloodstream positive negative 5-Fluorouracil a type of chemotherapy drug commonly used in treatment of colorectal cancer 10

11 References Adjuvant chemotherapy 1. Andre, T., et al., Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med, (23): p de Gramont, A. and e. al., Oxaliplatin/5-FU/LV in the adjuvant treatment of stage II and stage III colon cancer: efficacy results with a median followup of 4 years. Proc Am Soc Clin Oncol 2005, : Abstract Gray, R., QUASAR: a randomized study adjuvant chemotherapy (CT) vs observation including 3238 colorectal patients. Proc Am Soc Clin Oncol 2004, : Abstr Compton, C., et al., Prognostic factors in colorectal cancer. College of American Pathologist Consensus Statement Archives Pathology Laboratory Medicine, : p Mamounas, E., et al., Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer: results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04). J Clin Oncol, (5): p Berger, A.C., et al., Colon cancer survival is associated with decreasing ratio of metastatic to examined lymph nodes. J Clin Oncol, (34): p Twelves, C., et al., Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med, (26): p Palliative Chemotherapy 1. Cassidy, J., Tabernero, J., Twelves, C., Brunet, R., Butts, C., Conroy, T., Debraud, F., Figer, A., Grossmann, J., Sawada, N., Schoffski, P., Sobrero, A., Van Cutsem, E. & Diaz-Rubio, E. (2004). XELOX (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer. J Clin Oncol, 22, Douillard, J.Y., Cunningham, D., Roth, A.D., Navarro, M., James, R.D., Karasek, P., Jandik, P., Iveson, T., Carmichael, J., Alakl, M., Gruia, G., Awad, L. & Rougier, P. (2000). Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet, 355, Tournigand, C., Andre, T., Achille, E., Lledo, G., Flesh, M., Mery-Mignard, D., Quinaux, E., Couteau, C., Buyse, M., Ganem, G., Landi, B., Colin, P., Louvet, C. & de Gramont, A. (2004). FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol, 22, Epub 2003 Dec Waterston A and Cassidy J. Evidence and opinion for the use of combination therapy in the management of advanced Disease The Effective Management of Colorectal Cancer. UK Key Advances in Clinical Practice Series London. Aesculapius medical press 5. Cunningham, D., Pyrhonen, S., James, R.D., Punt, C.J., Hickish, T.F., Heikkila, R., Johannesen, T.B., Starkhammar, H., Topham, C.A., Awad, L., Jacques, C. & Herait, P. (1998). Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet, 352, Rougier, P., Van Cutsem, E., Bajetta, E., Niederle, N., Possinger, K., Labianca, R., Navarro, M., Morant, R., Bleiberg, H., Wils, J., Awad, L., Herait, P. & Jacques, C. (1998). Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet, 352, Folprecht, G., Gruenberger, T., Bechstein, WO., et al. (2010). Tumour response and secondary resectability of colorectal liver metastases following neoadjuvant chemotherapy with cetuximab: the CELIM randomised phase 2 trial. Lancet Oncology, 11, Van Custem, E. (2010)Cetuximab plus FOLFIRI in the treatment of metastatic colorectal cancer the influence of KRAS and BRAF biomarkers on outcome: Updated data from the CRYSTAL trial. ASCO GI, Abstract Follow up Colorectal Cancer Surveillance: 2005 Update of an American Society of Clinical Oncology Practice Guideline Christopher E. Desch, Al B. Benson, III, Mark R. Somerfield, Patrick J. Flynn, Carol Krause, Charles L. Loprinzi, Bruce D. Minsky, David G. Pfister, Katherine S. Virgo, Nicholas J. Petrelli, for the American Society of Clinical Oncology JCO v :