Anal Cancer Treatment Regimens

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ANAL CARCINOMA TREATMENT REGIMENS

(Revised 3/2018)

© 2018 Haymarket Media, Inc.

Clinical Trials: The National Comprehensive Cancer Network (NCCN) recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The NCCN Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any NCCN Guidelines® is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient's care or treatment. The NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Localized Cancer1

Note: All recommendations are category 2A unless otherwise indicated.

REGIMEN

DOSING

5-fluorouracil (5-FU) + mitomycin + radiotherapy2,3a

Days 1–4 and 29–32: 5-FU 1,000mg/m2/day continuous IV infusion

Days 1 and 29: Mitomycin 10mg/m2 IV bolus (maximum 20mg per course), plus

Concurrent radiotherapy.

OR

Days 1–4 and 29–32: 5-FU 1,000mg/m2/day continuous IV infusion

Day 1: Mitomycin 12mg/m2 (capped at 20mg), plus

Concurrent radiotherapy.

Capecitabine + mitomycin + radiotherapy4,5

Capecitabine 825mg/m2 orally twice daily, Monday–Friday, on each day that radiotherapy is given, throughout the duration of radiotherapy (typically 28 treatment days), plus

Days 1 and 29: Mitomycin 10mg/m2 IV bolus, plus

Concurrent radiotherapy.

OR

Days 1–5: Capecitabine 825mg/m2 orally twice daily weekly for 6 weeks, plus

Day 1: Mitomycin 12mg/m2 IV bolus, plus

Concurrent radiotherapy.

5-FU + cisplatin6 (category 2B)

Days 1–4: 5-FU 1,000mg/m2/day continuous IV infusion

Day 1: Cisplatin 75mg/m2 IV

Repeat cycle every 4 weeks, plus

Concurrent radiotherapy.

Metastatic Cancer1

5-FU + cisplatin6

Days 1–4: 5-FU 1,000mg/m2/day continuous IV infusion

Day 1: Cisplatin 60mg/m2 IV.

Repeat cycle every 3 weeks.7

OR

Days 1–5: 5-FU 750mg/m2/day continuous infusion

Day 1: Cisplatin 75mg/m2 IV.

Repeat cycle every 4 weeks.8

mFOLFOX69

Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV bolus

Days 2-3: 5-FU 1200mg/m2/day continuous IV infusion (total 2,400mg/m2 over 46-48 hours).

Repeat cycle every 2 weeks.

Carboplatin + paclitaxel10

Day 1: Carboplatin AUC 5 IV + paclitaxel 175mg/mg2 IV.

Repeat cycle every 3 weeks.

Subsequent Therapy

Nivolumab10

Day 1: Nivolumab 240mg IV

OR

Day 1: Nivolumab 3mg/kg IV.

Repeat cycle every 2 weeks.

Pembrolizumab11

Day 1: Pembrolizumab 200mg IV

OR

Day 1: Pembrolizumab 2mg/kg IV.

Repeat cycle every 3 weeks.

NOTE: Patients with anal cancer as the first manifestation of HIV may be treated with the same regimen as non-HIV patients. Patients with active HIV/AIDS-related complications or a history of complications (eg, malignancies, opportunistic infections) may not tolerate full-dose therapy or may not tolerate mitomycin an require dosage adjustment or treatment without mitomycin.

a For radiotherapy dosing, please see NCCN Anal Carcinoma Guidelines v 2.2017 “Principles of radiation therapy.”

References

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology™. Anal Carcinoma. v 1.2018. Available at: http://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed March 14, 2018.

2. Ajani JA, Winter KA, Gunderson LL, et al. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008;299(16):1914–1921.

3. James RD, Glynne-Jones R, Meadows HM, et al. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2×2 factorial trial. Lancet Oncol. 2013;14(6):516–524.

4. Goodman KA, Rothenstein D, Cambridge L, et al. Capecitabine plus mitomycin in patients undergoing definitive chemoradiation for anal squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2014;90(1):S32–S33.

5. Thind G, Johal B, Follwell M, Kennecke HF. Chemoradiation with capecitabine and mitomycin-C for stage I-III anal squamous cell carcinoma. Radiation Oncology. 2014;9:124.

6. Gunderson LL, Winter KA, Ajani JA, et al. Long-term update of US Intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012;30:4344-4351.

7. International multicentre study in advanced anal cancer comparing cisplatin plus 5-FU vs carboplatin plus weekly paclitaxel (InterAACT). ClinicalTrials.gov Identifier: NCT02051868.

8. Eng C, Chang GJ, You YN, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget. 2014;5: 11133-11142.

9. Matsunaga M, Miwa K, Oka Y, et al. Successful treatment of metastatic anal canal adenocarcinoma with mFOLFOX + bevacizumab. Case Rep Oncol. 2016;9:249-254.

10. Morris VK, Salem ME, Nimeiri H, et al. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicenter, single-arm, phase 2 study. Lancet Oncol. 2017;18:446-453.

11. Ott PA, Piha-Paul SA, Munster P, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinomma of the anal canal. Ann Oncol. 2017;28:1036-1041.


Gastrointestinal Cancer Drug Monographs

Colorectal and Other GI Cancers

AVASTIN CAMPTOSAR CYRAMZA
Doxorubicin HCl Doxorubicin HCl Solution ELOXATIN
ERBITUX Floxuridine Fluorouracil
FUSILEV GLEEVEC HERCEPTIN
Leucovorin LONSURF Mitomycin
NEXAVAR PHOTOFRIN STIVARGA
SUTENT TAXOTERE VECTIBIX
XELODA ZALTRAP

Pancreatic, Thyroid, And Other Endocrine Cancers

ABRAXANE AFINITOR CAPRELSA
COMETRIQ Doxorubicin HCl Doxorubicin HCl Solution
Fluorouracil GEMZAR LENVIMA
LYSODREN Mitomycin NEXAVAR
ONIVYDE SOMATULINE DEPOT SUTENT
TARCEVA THYROGEN ZANOSAR

Data provided by the Monthly Prescribing Reference (MPR) Hematology/Oncology Edition.

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