Gastric Cancer Treatment Regimens

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GASTRIC CANCER TREATMENT REGIMENS

The selection, dosing, and administration of anticancer agents and the management of associated toxicities are complex. Drug dose modifications and schedule and initiation of supportive care interventions are often necessary because of expected toxicities and because of individual patient variability, prior treatment, and comorbidities. Thus, the optimal delivery of anticancer agents requires a healthcare delivery team experienced in the use of such agents and the management of associated toxicities in patients with cancer. The cancer treatment regimens below may include both FDA-approved and unapproved uses/regimens and are provided as references only to the latest treatment strategies. Clinicians must choose and verify treatment options based on the individual patient.

General treatment notes: In response to the shortage of leucovorin, the FDA recently approved levoleucovorin (Fusilev) to be used in place of leucovorin when 5-FU is part of the regimen. Levoleucovorin 200mg/m2 is the equivalent of leucovorin 400mg/m2.1

REGIMEN

DOSING

Preoperative and Postoperative Chemotherapy (Only for Adenocarcinoma of the Distal Esophagus or Esophagogastric Junction)

ECF (epirubicin [Ellence] + cisplatin [Platinol; CDDP] + 

5-fluorouracil [5-FU])1–3

Days 1: Epirubicin 50mg/m2 IV bolus + cisplatin 60mg/m2 IV.

Days 1–21: 5-FU 200mg/m2 IV continuous infusion over 24 hours daily.

Repeat cycle every 3 weeks for 3 cycles preoperatively and 3 cycles postoperatively.

NOTE: Modified regimens substituting oxaliplatin and/or capecitabine are also acceptable.

Preoperative Chemoradiation

Cisplatin + 5-FU1,4

NOTE: Category 1

Days 1 and 29: Cisplatin 75–100mg/m2 IV.

Day 1–4 and 29–32: 5-FU 750–1,000mg/m2 IV continuous infusion over 24 hrs.

Cisplatin + capecitabine1,5

Day 1: Cisplatin 30mg/m2 IV.

Days 1–5: Capecitabine 800mg/m2 orally twice daily.

Repeat cycle weekly for 5 weeks.

Oxaliplatin + 5-FU1,6

Days 1, 15, and 29: Oxaliplatin 85mg/m2 IV.

Days 1–33: 5-FU 180mg/m2 IV.

Oxaliplatin + 5-FU1,7

Days 1, 8, 15, 22, and 29: Oxaliplatin 45mg/m2 IV.

Days 1–33: 5-FU 225mg/m2 IV continuous infusion over 24 hrs.

Oxaliplatin + capecitabine1,8

Days 1, 15, and 29: Oxaliplatin 85mg/m2 IV.

Days 1–5: Capecitabine 625mg/m2 orally twice daily for 5 weeks.

Paclitaxel + carboplatin1,9,10

NOTE: Category 1

Day 1: Paclitaxel 50mg/m2 IV + carboplatin AUC 2 IV.

Repeat weekly for 5 weeks.

Paclitaxel + cisplatin1,7

Days 1, 8, 15, and 22: Paclitaxel 60mg/m2 IV.

Day 1: Cisplatin 75mg/m2 IV.

Given for 1 cycle.

Postoperative Chemoradiation (Only for Adenocarcinoma or Gastroesophageal Junction)

5-FU + leucovorin1,11

Days 1–5: 5-FU 425mg/m2/day IV and leucovorin 20mg/m2/day IV, followed by chemoradiotherapy beginning 4 weeks after the start of the initial cycle of chemotherapy.

Chemoradiotherapy: 4,500cGy of radiation at 180cGy/day, 5 days/week for 5 weeks, with 5-FU 400mg/m2/day IV and leucovorin 20mg/m2/day IV on the first 4 and the last 3 days of radiotherapy.

At 1 month following completion of radiotherapy, two 5-day cycles of 5-FU 425mg/m2/day IV and leucovorin 20mg/m2/day IV; given 1 month apart.

Metastatic or Locally Advanced Cancer (Where Chemoradiation is Not Indicated)

DCF (docetaxel + cisplatin + 

5-FU)1,12

Day 1: Docetaxel 75mg/m2 IV + cisplatin 75mg/m2 IV.

Days 1–5: 5-FU 750mg/m2/day IV.

Repeat cycle every 3 weeks.

                                             OR                                                

Day 1: Docetaxel 75mg/m2 IV + cisplatin 75mg/m2 IV.

Days 1–5: 5-FU 1,000mg/m2 IV continuous infusion over 24 hrs, daily.

Repeat cycle every 4 weeks.

Modified DCF (docetaxel + leucovorin + cisplatin + 5-FU)1,13

Day 1: Docetaxel 40mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV, plus

Days 1 and 2: 5-FU 1,000mg/m2 IV continuous infusion over 24 hrs (total 2,000mg/m2), followed by

Day 3: Cisplatin 40mg/m2 IV.

Repeat cycle every 2 weeks.

Modified DCF (docetaxel + oxaliplatin + 5-FU)1,14

Day 1: Docetaxel 50mg/m2.

Day 1: Oxaliplatin 85mg/m2.

Days 1 and 2: 5-FU 1,200mg/m2 IV continuous infusion.

Repeat cycle every 2 weeks.

Cisplatin + leucovorin + 5-FU1,15

NOTE: Category 1

Day 1: Cisplatin 50mg/m2 IV.

Day 1: Leucovorin 200mg/m2 IV.

Day 1: 5-FU 2,000mg/m2 IV continuous infusion over 24 hrs.

Repeat cycle every 2 weeks.

Cisplatin + capecitabine1,16

Day 1: Cisplatin 80mg/m2 IV.

Day 1–14: Capecitabine 1,000mg/m2 orally twice daily.

Repeat cycle every 3 weeks.

ECF (epirubicin + cisplatin + 

5-FU)1,17

5-FU 200mg/m2/day as continuous IV infusion using a portable pump for up to 6 months, plus

Epirubicin 50mg/m2 IV and cisplatin 60mg/m2 IV infusion given as an inpatient procedure every 3 weeks for max 8 cycles.

                                                OR                                             

Day 1: Epirubicin 50mg/m2 IV bolus and cisplatin 60mg/m2 IV, plus

Days 1–21: 5-FU 200mg/m2/day IV.

Repeat cycle every 3 weeks for max 8 cycles.

ECX (epirubicin + cisplatin + capecitabine [Xeloda])1,3

Day 1: Epirubicin 50mg/m2 IV bolus and cisplatin 60mg/m2 IV, plus

Days 1–21: Capecitabine 625mg/m2 orally twice daily.

Repeat cycle every 3 weeks for max 8 cycles.

EOF (epirubicin + oxaliplatin + 

5-FU)1,3

Day 1: Epirubicin 50mg/m2 IV bolus and oxaliplatin 130mg/m2 IV, plus

Days 1–21: 5-FU 200mg/m2/day IV.

Repeat cycle every 3 weeks for max 8 cycles.

EOX (epirubicin + oxaliplatin + capecitabine)1,3

Day 1: Epirubicin 50mg/m2 IV bolus and oxaliplatin 130mg/m2 IV, plus

Days 1–21: Capecitabine 625mg/m2 orally twice daily.

Repeat cycle every 3 weeks for max 8 cycles.

Trastuzumab (Herceptin) + capecitabine/cisplatin OR          5-FU/cisplatin1,18

NOTE: For HER2-neu overexpressing adenocarcinoma.

Day 1: Trastuzumab 8mg/kg IV loading dose (Cycle 1 only); followed by trastuzumab 6mg/kg IV every 3 weeks, plus chemotherapy (see below).

Chemotherapy

Day 1: Cisplatin 80mg/m2 IV, plus

Days 1–14: Capecitabine 1,000mg/m2 orally twice daily OR

Days 1–5: 5-FU 800mg/m2 continuous IV infusion.

Repeat cycle every 3 weeks for 6 cycles.

References

  1. NCCN Clinical Practice Guidelines in Oncology™. Gastric Cancer. v 2.2011. Available at: http://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf. Accessed April 16, 2012.

  2. Cunningham D, Allum WH, Stenning SP, et al. MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006; 355:11–20.

  3. Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358:36–46.

  4. Tepper J, Krasna MJ, Niedzwiecki D, et al. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008;26:1086–1092.

  5. Lee SS, Kim SB, Park SI, et al. Capecitabine and cisplatin chemotherapy (XP) alone or sequentially combined chemoradiotherapy containing XP regiment in patients with three different settings of stage IV esophageal cancer. Jpn J Clin Oncol. 2007;37:829–835.

  6. Khushalani NI, Leichman CG, Proulx G, et al. Oxaliplatin in combination with protracted-infusion fluorouracil and radiation: report of a clinical trial for patients with esophageal cancer. J Clin Oncol. 2002;20:2844–2850.

  7. Urba SG, Orringer MB, Ianettonni M, et al. Concurrent cisplatin, paclitaxel, and radiotherapy as preoperative treatment for patients with locoregional esophageal carcinoma. Cancer. 2003;98:2177–2183.

  8. Javle MM, Yang G, Nwogu CE, et al. Capecitabine, oxaliplatin and radiotherapy: a phase 1B neoadjuvant study for esophageal cancer with gene expression analysis. Cancer Invest. 2009;27:193–200.

  9. van Meerten E, Muller K, Tilanus H, et al. Neoadjuvant concurrent chemoradiation with weekly paclitaxel and carboplatin for patients with oesophageal cancer: a phase II study. Br J Cancer. 2006;94:1389–1394.

10. Gaast AV, van Hagen P, Hulshof M, et al. Effect of preoperative concurrent chemoradiotherapy on survival of patients with resectable esophageal or esophagogastric junction cancer: results from a multicenter randomized phase III study [abstract].        J Clin Oncol. 2010;28:4004.

11. Macdonald JS, Smalley SR, Benedetti J, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001;345:725–730.

12. Van Cutsem E, Moiseyenko VM, Tjulandin S, et al. V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group.            J Clin Oncol. 2006;24:4991–4997.

13. Shah MA, Shibata S, Stoller RG, et al; MSKCC Gastric Cancer Consortium. Random assignment multicenter phase II study of modified docetaxel, cisplatin, fluorouracil (mDCF) versus DCF with growth factor support (GCSF) in metastatic gastroesophageal adenocarcinoma (GE). J Clin Oncol. 2010;28 (Suppl 15): 4010.

14. Shankaran V, Mulcahy MF, Hochster HS, et al. Docetaxel, oxaliplatin and 5-fluorouracil for the treatment of metastatic or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinomas: preliminary results of a phase II study [abstract]. Presented at the Gastrointestinal Cancers Symposium 2009; Abstract 47.

15. Al-Batran S-E, Hartmann JT, Probst S, et al. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008;26:1435–1442.

16. Kang YK, Kang WK, Shin DB, et al. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009;20:666–673.

17. Ross P, Nicolson M, Cunningham D, et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) With epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer.J Clin Oncol. 2002;20:1996–2004.

18. Bang YJ, Van Cutsem E, Feyereislova A, et al; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376(9742):687–697.


Gastrointestinal Cancer Drug Monographs

Colorectal and Other GI Cancers

Adriamycin Adriamycin Solution Adrucil
Avastin Camptosar Eloxatin
Erbitux Fusilev Gleevec
Leucovorin Nexavar Photofrin
Sutent Taxotere Vectibix
Xeloda

Pancreatic, Thyroid, And Other Endocrine Cancers

Adriamycin Adriamycin Solution Adrucil
Afinitor Caprelsa Gemzar
Lysodren Tarceva Thyrogen
Zanosar

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