Esophageal cancer

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Neoadjuvant chemoradiation

Carboplatin (Paraplatin) & Fluorouracil (5-FU)

Regimen

• Carboplatin (Paraplatin) AUC 6 IV on days 1 & 22
• Fluorouracil (5-FU) 200 mg/m2/day IV continuous infusion on days 1-42
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, starting on day 1, for a total dose of 45 Gy. If surgery was contraindicated, total dose was increased to 50.4-56.8 Gy.
• Upper endoscopy and CT chest and abdomen was performed after completion of chemoradiation
• Surgery planned to be done 4-6 weeks after finishing chemoradiation

42-day course

References

1. Zemanova M, Petruzelka L, Pazdro A, Kralova D, Smejkal M, Pazdrova G, Honova H. Prospective non-randomized study of preoperative concurrent platinum plus 5-fluorouracil-based chemoradiotherapy with or without paclitaxel in esophageal cancer patients: long-term follow-up. Dis Esophagus. 2010 Feb;23(2):160-7. Epub 2009 Jun 9. link to original article contains protocol PubMed

Carboplatin (Paraplatin) & Paclitaxel (Taxol)

Regimen

• Carboplatin (Paraplatin) AUC 2 IV on days 1, 8, 15, 22, 29; given second
• Paclitaxel (Taxol) 50 mg/m2 IV over 1 hour on days 1, 8, 15, 22, 29; given first
• Concurrent radiation therapy, 1.8 Gy fractions x 23 fractions given 5 days per week, starting on day 1, for a total dose of 41.4 Gy
• Surgery planned to be done within 6 weeks of finishing chemoradiation

5-week course

Supportive medications:

• Dexamethasone (Decadron) 10 mg IV 30 minutes prior to paclitaxel
• Ranitidine (Zantac) 50 mg IV 30 minutes prior to paclitaxel
• Clemastine 2 mg IV 30 minutes prior to paclitaxel
• Between paclitaxel & carboplatin: 100 mL NS given over 30 minutes, then ondansetron 8 mg in 100 mL NS given over 30 minutes

References

1. van Meerten E, Muller K, Tilanus HW, Siersema PD, Eijkenboom WM, van Dekken H, Tran TC, van der Gaast A. Neoadjuvant concurrent chemoradiation with weekly paclitaxel and carboplatin for patients with oesophageal cancer: a phase II study. Br J Cancer. 2006 May 22;94(10):1389-94. link to original article contains protocol PubMed

Carboplatin (Paraplatin), Paclitaxel (Taxol), Capecitabine (Xeloda)

Regimen

The primary reference did not specify whether patients were intended to proceed to surgery.

• Carboplatin (Paraplatin) AUC 1.5 IV on days 2, 9, 16, 23, 30
• Paclitaxel (Taxol) 45 mg/m2 IV over 1 hour on days 2, 9, 16, 23, 30
• Capecitabine (Xeloda) 600 mg/m2 PO BID, starting on day 1 and finishing the evening of the last day of radiation therapy
• Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy, starting on day 1

6-week course

References

1. Czito BG, Kelsey CR, Hurwitz HI, Willett CG, Morse MA, Blobe GC, Fernando NH, D'Amico TA, Harpole DH, Honeycutt W, Yu D, Bendell JC. A Phase I study of capecitabine, carboplatin, and paclitaxel with external beam radiation therapy for esophageal carcinoma. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1002-7. Epub 2006 Dec 29. link to original article contains protocol PubMed

Cisplatin (Platinol) & Capecitabine (Xeloda)

Regimen

Note: This is listed as a neoadjuvant regimen by the NCCN, Esophageal Cancer version 2.2011, but the study was for patients with stage IV disease. Please reference the original paper, as there were no patients who only received this neoadjuvant treatment, and they did not undergo surgical resection of disease.

• Cisplatin (Platinol) 30 mg/m2 IV over 1 hour on day 1; given before the first dose of capecitabine
• Capecitabine (Xeloda) 800 mg/m2 PO BID, 5 days per week while radiation is being given
• Concurrent radiation therapy, total of 54 Gy given (dose per fraction and total duration of treatment was not specified)

References

1. Lee SS, Kim SB, Park SI, Kim YH, Ryu JS, Song HY, Shin JH, Jung HY, Lee GH, Choi KD, Cho KJ, Kim JH. Capecitabine and cisplatin chemotherapy (XP) alone or sequentially combined chemoradiotherapy containing XP regimen in patients with three different settings of stage IV esophageal cancer. Jpn J Clin Oncol. 2007 Nov;37(11):829-35. Epub 2007 Oct 19. link to original article contains protocol--please see note above, as patients in this study did not undergo surgery PubMed

Cisplatin (Platinol) & Docetaxel (Taxotere)

Regimen

• Cisplatin (Platinol) 75 mg/m2 IV on day 1
• Docetaxel (Taxotere) 75 mg/m2 IV on day 1

21-day cycles x 2 cycles, THEN

• Cisplatin (Platinol) 25 mg/m2 IV on days 1, 8, 15, 22, 29
• Docetaxel (Taxotere) 20 mg/m2 IV on days 1, 8, 15, 22, 29
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, starting on day 1, for a total dose of 45 Gy.
• Surgery planned to be done 3-8 weeks after finishing chemoradiation

5-week course

References

1. Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, Balmermajno S, Köberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-8. Epub 2009 May 22. link to original article contains protocol PubMed

Cisplatin (Platinol) & Fluorouracil (5-FU)

Regimen #1, Tepper, et al. 2008

• Cisplatin (Platinol) 100 mg/m2 IV over 30 minutes on days 1 & 29; given first
• Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours (total dose 4000 mg/m2) on days 1-4, 29-32; given after cisplatin
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, then a 5.4 Gy final boost, for a total dose of 50.4 Gy, starting within 24 hours of chemotherapy
• EGD and CT chest and abdomen done within 4 weeks after finishing radiation therapy. Only patients who still had resectable disease that was stable or responded would proceed to surgery. Surgery was planned to be done 3-8 weeks after finishing chemoradiation.

5.5-week course

Regimen #2, Bedenne, et al. 2007

Study did not show a benefit of surgery after 2 cycles of chemoradiation as compared to additional chemoradiation.

• Cisplatin (Platinol) 15 mg/m2 IV over 1 hour on days 1-5
• Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours (total dose 4000 mg/m2) on days 1-5
• Conventional radiation therapy, 2 Gy fractions x 23 fractions given 5 days per week, for a total dose of 46 Gy
  • Earlier in the study, some patients instead received split-course radiation therapy, 3 Gy fractions x 5 fractions given on days 1-5. 15 Gy per cycle; total dose after 2 cycles is 30 Gy.
• Surgery to be done 50-60 days after start of chemoradiation

21-day cycles x 2 cycles

Supportive hydration:

• 1 liter NS IV over 2 hours before and after cisplatin

References

1. Bedenne L, Michel P, Bouché O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. link to original article contains protocol PubMed
2. Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. 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 Mar 1;26(7):1086-92. link to original article contains protocol PubMed

Cisplatin (Platinol) & Fluorouracil (5-FU) -> Paclitaxel (Taxol), Fluorouracil (5-FU), RT

Regimen

• Cisplatin (Platinol) 20 mg/m2 IV on days 1 & 5
• Fluorouracil (5-FU) 200 mg/m2/day IV continous infusion on days 1-21

28-day cycles x 2 cycles, THEN

• Paclitaxel (Taxol) 45 mg/m2 IV on days 1, 8, 15, 22, 29
• Fluorouracil (5-FU) 300 mg/m2/day IV continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, for a total dose of 45 Gy

5-week course

References

1. Ajani JA, Winter K, Okawara GS, Donohue JH, Pisters PW, Crane CH, Greskovich JF, Anne PR, Bradley JD, Willett C, Rich TA. Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined modality therapy and pathologic response. J Clin Oncol. 2006 Aug 20;24(24):3953-8. link to original article contains protocol PubMed

Cisplatin (Platinol) & Irinotecan (Camptosar)

Regimen #1, Ilson, et al. 2011

• Cisplatin (Platinol) 30 mg/m2 IV over 30 minutes on days 1 & 8; given before irinotecan
• Irinotecan (Camptosar) 65 mg/m2 IV over 30 minutes on days 1 & 8; given after cisplatin

21-day cycles x 2 cycles, THEN

• Cisplatin (Platinol) 30 mg/m2 IV over 30 minutes on days 1 & 8; given before irinotecan
• Irinotecan (Camptosar) 65 mg/m2 IV over 30 minutes on days 1 & 8; given after cisplatin
• Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total of 50.4 Gy given
• Surgery performed 4-8 weeks after chemoradiation

21-day cycles x 2 cycles

Supportive medications:

• Dexamethasone (Decadron) 20 mg PO/IV prior to chemotherapy
• Granisetron 2 mg PO or ondansetron 32 mg IV prior to chemotherapy
• At least 500 mL D5NS or NS as supportive hydration
• Atropine 0.5-1 mg IV prn cholinergic symptoms

Regimen #2, Rivera, et al. 2009

• Cisplatin (Platinol) 30 mg/m2 IV on days 1, 8, 22, 29
• Irinotecan (Camptosar) 65 mg/m2 IV on days 1, 8, 22, 29

21-day cycles x 2 cycles, THEN

• Cisplatin (Platinol) 30 mg/m2 IV on days 1, 8, 15, 22
• Irinotecan (Camptosar) 65 mg/m2 IV on days 1, 8, 15, 22
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, starting within 24 hours of the first dose of chemotherapy, for a total dose of 45 Gy.
• Surgery done 5-8 weeks after finishing chemoradiation

5-week course

Regimen #3, Yoon, et al. 2011

Note: In contrast to the original reference, the NCCN, Esophageal Cancer version 2.2011, lists the dosage of preoperative irinotecan as 50 mg/m2.

• Cisplatin (Platinol) 30 mg/m2 IV on days 1, 8, 22, 29
• Irinotecan (Camptosar) 65 mg/m2 IV on days 1, 8, 22, 29
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, starting within 24 hours of the first dose of chemotherapy, for a total dose of 45 Gy.

5-week course, THEN

• Surgery done at least 28 days after finishing chemoradiation, then begin adjuvant chemotherapy at least 28 days after surgical resection:
• Cisplatin (Platinol) 30 mg/m2 IV on days 1 & 8
• Irinotecan (Camptosar) 65 mg/m2 IV on days 1 & 8

21-day cycles x 3 cycles

Regimen #4, Sharma, et al. 2009

• Cisplatin (Platinol) 30 mg/m2 IV on days 1 & 8
• Irinotecan (Camptosar) 65 mg/m2 IV on days 1 & 8
• Concurrent radiation therapy, 1.8 Gy fractions x 25-28 fractions, for a total of 45-50.4 Gy given

21-day cycles x 2 cycles (2 cycles per NCCN, Esophageal Cancer version 2.2011; abstract did not specify number of cycles)

References

1. R. Sharma, G. Y. Yang, H. R. Nava, T. L. Demmy, C. E. Nwogu, S. S. Yendamuri, D. Lamonica, W. Tan, R. V. Iyer, N. I. Khushalani. A single institution experience with neoadjuvant chemoradiation (CRT) with irinotecan (I) and cisplatin (C) in locally advanced esophageal carcinoma (LAEC). 2009 ASCO Annual Meeting abstract e15619. link to abstract
2. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer (Regimen #2, Rivera, et al. 2009, clinicaltrials.gov)
3. Rivera F, Galán M, Tabernero J, Cervantes A, Vega-Villegas ME, Gallego J, Laquente B, Rodríguez E, Carrato A, Escudero P, Massutí B, Alonso-Orduña V, Cardenal A, Sáenz A, Giralt J, Yuste AL, Antón A, Aranda E; Spanish Cooperative Group for Digestive Tumor Therapy. Phase II trial of preoperative irinotecan-cisplatin followed by concurrent irinotecan-cisplatin and radiotherapy for resectable locally advanced gastric and esophagogastric junction adenocarcinoma. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1430-6. Epub 2009 Jun 18. link to original article contains protocol PubMed
4. Ilson DH, Minsky BD, Ku GY, Rusch V, Rizk N, Shah M, Kelsen DP, Capanu M, Tang L, Campbell J, Bains M. Phase 2 trial of induction and concurrent chemoradiotherapy with weekly irinotecan and cisplatin followed by surgery for esophageal cancer. Cancer. 2011 Oct 11. doi: 10.1002/cncr.26591. link to original article contains protocol PubMed
5. Yoon HH, Catalano P, Gibson MK, Skaar TC, Philips S, Montgomery EA, Hafez MJ, Powell M, Liu G, Forastiere AA, Benson AB, Kleinberg LR, Murphy KM. Genetic variation in radiation and platinum pathways predicts severe acute radiation toxicity in patients with esophageal adenocarcinoma treated with cisplatin-based preoperative radiochemotherapy: results from the Eastern Cooperative Oncology Group. Cancer Chemother Pharmacol. 2011 Oct;68(4):863-70. Epub 2011 Feb 1. link to original article contains protocol PubMed

Cisplatin (Platinol) & Paclitaxel (Taxol)

Regimen

• Cisplatin (Platinol) 75 mg/m2 IV over 2 hours on day 1
• Paclitaxel (Taxol) 60 mg/m2 IV over 3 hours on days 1, 8, 15, 22
• Concurrent radiation therapy, 1.5 Gy fractions given twice per day on days 1-5, 8-12, 15-19, with at least 6 hours between fractions, for a total dose of 45 Gy
• Barium swallow and CT chest and abdomen done about 1 week prior to surgery to rule out metastatic disease
• Surgery to be done on approximately day 50

4-week course of therapy

Supportive medications:

• Dexamethasone (Decadron) 20 mg PO given 12 and 6 hours before paclitaxel
• Diphenhydramine (Benadryl) 50 mg IV 30 minutes prior to paclitaxel
• Cimetidine (Tagamet) 300 mg IV 30 minutes prior to paclitaxel
• 1 liter D5NS and mannitol 12.5 g bolus IV prior to cisplatin
• Mannitol 25 g in 1 liter D5NS IV over 4 hours after cisplatin
• Filgrastim (Neupogen) 5 mcg/kg SC daily, starting 24 hours after the fourth dose of paclitaxel, continuing until absolute neutrophil count >10,000

Regimen #2, Yoon, et al. 2011

• Cisplatin (Platinol) 30 mg/m2 IV on days 1, 8, 15, 22, 29
• Paclitaxel (Taxol) 50 mg/m2 IV over 1 hour on days 1, 8, 15, 22, 29
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, starting within 24 hours of the first dose of chemotherapy, for a total dose of 45 Gy.

5-week course, THEN

• Surgery done at least 28 days after finishing chemoradiation, then begin adjuvant chemotherapy at least 28 days after surgical resection:
• Cisplatin (Platinol) 75 mg/m2 IV on day 1
• Paclitaxel (Taxol) 175 mg/m2 IV on day 1

21-day cycles x 3 cycles

References

1. Urba SG, Orringer MB, Ianettonni M, Hayman JA, Satoru H. Concurrent cisplatin, paclitaxel, and radiotherapy as preoperative treatment for patients with locoregional esophageal carcinoma. Cancer. 2003 Nov 15;98(10):2177-83. link to original article contains protocol PubMed
2. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer (Regimen #2, Yoon, et al. 2011, clinicaltrials.gov)
3. Yoon HH, Catalano P, Gibson MK, Skaar TC, Philips S, Montgomery EA, Hafez MJ, Powell M, Liu G, Forastiere AA, Benson AB, Kleinberg LR, Murphy KM. Genetic variation in radiation and platinum pathways predicts severe acute radiation toxicity in patients with esophageal adenocarcinoma treated with cisplatin-based preoperative radiochemotherapy: results from the Eastern Cooperative Oncology Group. Cancer Chemother Pharmacol. 2011 Oct;68(4):863-70. Epub 2011 Feb 1. link to original article contains protocol PubMed

Docetaxel (Taxotere) & Capecitabine (Xeloda)

Regimen

Note: Neither of the references cited for this regimen by the NCCN, Esophageal Cancer version 2.2011, actually contained this regimen. No primary reference could be found for this regimen.

• Docetaxel (Taxotere) 20 mg/m2 IV on days 1, 8, 15, 22, 29
• Capecitabine (Xeloda) 625-825 mg/m2 PO BID on days 1-5, 8-12, 15-19, 22-26, 29-33

5-week course

Docetaxel (Taxotere) & Fluorouracil (5-FU)

Regimen #1, Hihara, et al. 2007

• Docetaxel (Taxotere) 7.5 mg/m2 IV over 1 hour on days 1, 8, 22, 29
• Fluorouracil (5-FU) 250 mg/m2/day IV continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, 43-45
• Concurrent radiation therapy, 2 Gy fractions x 30-33 fractions given 5 days per week (i.e. on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, 43-45), for a total dose of 60-66 Gy, starting on day 1

Supportive medications:

• Dexamethasone (Decadron) 8 mg IV 30 minutes prior to docetaxel

7-week course

Regimen #2

Note: Neither of the references cited for this regimen by the NCCN, Esophageal Cancer version 2.2011, actually contained this regimen. No primary reference could be found for this regimen.

• Docetaxel (Taxotere) 20 mg/m2 IV on days 1, 8, 15, 22, 29
• Fluorouracil (5-FU) 200-300 mg/m2/day IV continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33

5-week course

References

1. Hihara J, Yoshida K, Hamai Y, Emi M, Yamaguchi Y, Wadasaki K. Phase I study of docetaxel (TXT) and 5-fluorouracil (5-FU) with concurrent radiotherapy in patients with advanced esophageal cancer. Anticancer Res. 2007 Jul-Aug;27(4C):2597-603. link to original article contains protocol PubMed

Oxaliplatin (Eloxatin) & Capecitabine (Xeloda)

Regimen

Primary reference was not able to be obtained to verify this regimen.

• Oxaliplatin (Eloxatin) 85 mg/m2 IV on days 1, 15, 29
• Capecitabine (Xeloda) 625 mg/m2 PO BID on days 1-5, 8-12, 15-19, 22-26, 29-33
• Concurrent radiation therapy, total dose of 50.4 Gy

5-week course

References

1. Javle MM, Yang G, Nwogu CE, Wilding GE, O'Malley L, Vinjamaram S, Schiff MD, Nava HR, LeVea C, Clark KR, Prey JD, Smith PF, Pendyala L. Capecitabine, oxaliplatin and radiotherapy: a phase IB neoadjuvant study for esophageal cancer with gene expression analysis. Cancer Invest. 2009 Feb;27(2):193-200. link to original article PubMed

Oxaliplatin (Eloxatin), Docetaxel (Taxotere), Capecitabine (Xeloda)

Regimen

• Oxaliplatin (Eloxatin) 40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, 29
• Docetaxel (Taxotere) 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, 29
• Capecitabine (Xeloda) 1000 mg/m2 PO BID on days 1-7, 15-21, 29-35
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions, for a total dose of 45 Gy. Patients who were no longer surgical candidates received additional radiation therapy to a total dose of 64.8 Gy.
• Endoscopy, CT scan, and--if available--endoscopic ultrasound for restaging 2-4 weeks after finishing chemoradiation
• Surgical resection for appropriate candidates during weeks 9-12

5-week course of therapy

Supportive medications:

• Dexamethasone (Decadron) 4 mg PO every 12 hours before, at the time of, and after docetaxel; first dose the evening before docetaxel
• "Routine antiemetics"

References

1. Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. Epub 2010 Mar 29. link to original article contains protocol PubMed

Oxaliplatin (Eloxatin) & Fluorouracil (5-FU)

Regimen #1, Lorenzen, et al. 2008

• Oxaliplatin (Eloxatin) 45 mg/m2 IV over 2 hours on days 1, 8, 15, 22, 29
• Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion over days 1-33
• Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, for a total dose of 45 Gy
• Surgery 4-6 weeks after finishing chemoradiation

35-day course

Regimen #2, Khushalani, et al. 2002

Note: In contrast to the original reference, the NCCN, Esophageal Cancer version 2.2011 lists Fluorouracil (5-FU) as being given on days 1-33.

• Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours on days 1, 15, 29
• Fluorouracil (5-FU) 180 mg/m2/day IV continuous infusion over days 8-42
• Concurrent radiation therapy, 1.8 Gy fractions x 20-22 fractions, for an initial total dose of 36-39.6 Gy, started on day 8
  • Followed by off-cord conformal oblique fields, 5.4-9 Gy given to the clinical target volume (CTV). A second off-cord phase to the gross tumor volume (GTV) of 5.4 Gy was then given, for a total dose delivered of 50.4 Gy to the GTV.
• Upper GI endoscopy and CT chest, abdomen, and pelvis were done after completion of chemoradiation, and patients without progressive stage II-III disease were offered surgery followed by another cycle of oxaliplatin and 5-FU. Patients who could not proceed to surgery were given another 1-2 cycles of oxaliplatin and 5-FU within 2 weeks.

6-week cycle x 1 initial cycle (see above)

References

1. Khushalani NI, Leichman CG, Proulx G, Nava H, Bodnar L, Klippenstein D, Litwin A, Smith J, Nava E, Pendyala L, Smith P, Greco W, Berdzik J, Douglass H, Leichman L. Oxaliplatin in combination with protracted-infusion fluorouracil and radiation: report of a clinical trial for patients with esophageal cancer. J Clin Oncol. 2002 Jun 15;20(12):2844-50. link to original article contains protocol PubMed
2. Lorenzen S, Brücher B, Zimmermann F, Geinitz H, Riera J, Schuster T, Roethling N, Höfler H, Ott K, Peschel C, Siewert JR, Molls M, Lordick F. Neoadjuvant continuous infusion of weekly 5-fluorouracil and escalating doses of oxaliplatin plus concurrent radiation in locally advanced oesophageal squamous cell carcinoma: results of a phase I/II trial. Br J Cancer. 2008 Oct 7;99(7):1020-6. Epub 2008 Sep 16. link to original article contains protocol PubMed

Paclitaxel (Taxol) & Capecitabine (Xeloda)

Regimen

Note: Neither of the references cited for this regimen by the NCCN, Esophageal Cancer version 2.2011, actually contained this regimen. No primary reference could be found for this regimen.

• Paclitaxel (Taxol) 45-50 mg/m2 IV on days 1, 8, 15, 22, 29
• Capecitabine (Xeloda) 625-825 mg/m2 PO BID on days 1-5, 8-12, 15-19, 22-26, 29-33

5-week course

Perioperative chemotherapy

ECF, "MAGIC Trial"

ECF: Epirubicin, Cisplatin, Fluorouracil

Regimen

• Epirubicin (Ellence) 50 mg/m2 IV bolus on day 1
• Cisplatin (Platinol) 60 mg/m2 IV on day 1
• Fluorouracil (5-FU) 200 mg/m2/day IV continuous infusion on days 1-21

21-day cycles x 3 cycles preoperatively, with surgery 3-6 weeks after completing cycle 3. The 3 cycles of postoperative chemotherapy are started 6-12 weeks after surgery.

Supportive medications:

• Warfarin (Coumadin) 1 mg PO daily recommended for thrombosis prophylaxis

References

1. Sumpter K, Harper-Wynne C, Cunningham D, Rao S, Tebbutt N, Norman AR, Ward C, Iveson T, Nicolson M, Hickish T, Hill M, Oates J. Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF. Br J Cancer. 2005 Jun 6;92(11):1976-83. link to original article contains protocol PubMed
2. Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. link to original article contains protocol PubMed

ECX

ECX: Epirubicin, Cisplatin, Xeloda

Regimen

This regimen is listed as a perioperative option by the NCCN, Esophageal Cancer version 2.2011, but it is not clearly described as one by the primary reference. Study participants could have had either locally advanced or metastatic disease, and the primary reference did not list a uniform policy about what patients underwent surgery and its timing--although a few patients were mentioned to undergo surgery. No follow-up report for this trial or its additional participants could be found.

• Epirubicin (Ellence) 50 mg/m2 IV bolus on day 1
• Cisplatin (Platinol) 60 mg/m2 IV on day 1
• Capecitabine (Xeloda) 500-625 mg/m2 PO BID on days 1-21

21-day cycles x up to 8 cycles; for perioperative use per NCCN, 3 cycles preoperatively and 3 cycles postoperatively would be used

Supportive medications:

• Dexamethasone (Decadron) 8 mg IV prior to day 1 chemotherapy and 4 mg PO TID x 2 days thereafter
• "5HT3 antagonist" prior to chemotherapy
• Metoclopramide (Reglan) 10 mg PO TID x 3 days after day 1 chemotherapy
• "Standard hydration" for cisplatin
• Warfarin (Coumadin) 1 mg PO daily as thrombosis prophylaxis, started on day -1

References

1. Sumpter K, Harper-Wynne C, Cunningham D, Rao S, Tebbutt N, Norman AR, Ward C, Iveson T, Nicolson M, Hickish T, Hill M, Oates J. Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF. Br J Cancer. 2005 Jun 6;92(11):1976-83. link to original article contains protocol PubMed

EOF

EOF: Epirubicin, Oxaliplatin, Fluorouracil

Regimen

This regimen is listed as a perioperative option by the NCCN, Esophageal Cancer version 2.2011, but it is not clearly described as one by the primary reference. Study participants could have had either locally advanced or metastatic disease, and the primary reference did not list a uniform policy about what patients underwent surgery and its timing--although a few patients were mentioned to undergo surgery. No follow-up report for this trial or its additional participants could be found.

• Epirubicin (Ellence) 50 mg/m2 IV bolus on day 1
• Oxaliplatin (Eloxatin) 130 mg/m2 IV over 2 hours on day 1
• Fluorouracil (5-FU) 200 mg/m2/day IV continuous infusion on days 1-21

21-day cycles x up to 8 cycles; for perioperative use per NCCN, 3 cycles preoperatively and 3 cycles postoperatively would be used

Supportive medications:

• Dexamethasone (Decadron) 8 mg IV prior to day 1 chemotherapy and 4 mg PO TID x 2 days thereafter
• "5HT3 antagonist" prior to chemotherapy
• Metoclopramide (Reglan) 10 mg PO TID x 3 days after day 1 chemotherapy
• Warfarin (Coumadin) 1 mg PO daily as thrombosis prophylaxis, started on day -1

References

1. Sumpter K, Harper-Wynne C, Cunningham D, Rao S, Tebbutt N, Norman AR, Ward C, Iveson T, Nicolson M, Hickish T, Hill M, Oates J. Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF. Br J Cancer. 2005 Jun 6;92(11):1976-83. link to original article contains protocol PubMed

EOX

EOX: Epirubicin, Oxaliplatin, Xeloda

Regimen

This regimen is listed as a perioperative option by the NCCN, Esophageal Cancer version 2.2011, but it is not clearly described as one by the primary reference. Study participants could have had either locally advanced or metastatic disease, and the primary reference did not list a uniform policy about what patients underwent surgery and its timing--although a few patients were mentioned to undergo surgery. No follow-up report for this trial or its additional participants could be found.

• Epirubicin (Ellence) 50 mg/m2 IV bolus on day 1
• Oxaliplatin (Eloxatin) 130 mg/m2 IV over 2 hours on day 1
• Capecitabine (Xeloda) 500-625 mg/m2 PO BID on days 1-21

21-day cycles x up to 8 cycles; for perioperative use per NCCN, 3 cycles preoperatively and 3 cycles postoperatively would be used

Supportive medications:

• Dexamethasone (Decadron) 8 mg IV prior to day 1 chemotherapy and 4 mg PO TID x 2 days thereafter
• "5HT3 antagonist" prior to chemotherapy
• Metoclopramide (Reglan) 10 mg PO TID x 3 days after day 1 chemotherapy
• Warfarin (Coumadin) 1 mg PO daily as thrombosis prophylaxis, started on day -1

References

1. Sumpter K, Harper-Wynne C, Cunningham D, Rao S, Tebbutt N, Norman AR, Ward C, Iveson T, Nicolson M, Hickish T, Hill M, Oates J. Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF. Br J Cancer. 2005 Jun 6;92(11):1976-83. link to original article contains protocol PubMed

Definitive chemoradiation (no surgery)

Carboplatin (Paraplatin) & Paclitaxel (Taxol)

See Carboplatin (Paraplatin) & Paclitaxel (Taxol), except patients did not undergo surgery.

Cisplatin (Platinol) & Capecitabine (Xeloda)

Regimen

The study was for patients with stage IV disease.

• Patients with M1b disease (visceral metastases) received the chemotherapy only part until progression of disease or unacceptable toxicity.
• Patients with M1a or M1b (non-viscertal metastases) received 2 cycles of the chemotherapy only part, underwent treatment with chemoradiation, and then treatment continued with--presumably, but not outright specified in the paper--chemotherapy only until progression of disease or unacceptable toxicity.

Chemotherapy only part:

• Cisplatin (Platinol) 60 mg/m2 IV over 1 hour on day 1; given before the first dose of capecitabine
• Capecitabine (Xeloda) 1000 mg/m2 PO BID on days 1-14

21-day cycles

Chemoradiation part:

• Cisplatin (Platinol) 30 mg/m2 IV over 1 hour on day 1; given before the first dose of capecitabine
• Capecitabine (Xeloda) 800 mg/m2 PO BID, 5 days per week while radiation is being given
• Concurrent radiation therapy, total of 54 Gy given. Dose per fraction and total duration of treatment were not specified, but based on other regimens, it is suspected to be either 1.8 Gy x 30 fractions or 2 Gy x 27 fractions.

1-week cycles until radiation therapy is complete

References

1. Lee SS, Kim SB, Park SI, Kim YH, Ryu JS, Song HY, Shin JH, Jung HY, Lee GH, Choi KD, Cho KJ, Kim JH. Capecitabine and cisplatin chemotherapy (XP) alone or sequentially combined chemoradiotherapy containing XP regimen in patients with three different settings of stage IV esophageal cancer. Jpn J Clin Oncol. 2007 Nov;37(11):829-35. Epub 2007 Oct 19. link to original article contains protocol PubMed

Cisplatin (Platinol) & Docetaxel (Taxotere)

Regimen #1, Li, et al. 2009

• Cisplatin (Platinol) 80 mg/m2 IV on days 1 & 22
• Docetaxel (Taxotere) 60 mg/m2 IV on days 1 & 22
• Concurrent radiation therapy, 1.8-2.0 Gy fractions, 5 days per week, to start within 24 hours of the day 1 of chemotherapy
  • Patients with stage I-III disease received a total dose of 60-64 Gy over 4-6 weeks
  • Patients with stage IV disease (lymph node only) received a total dose of 50-56 Gy

1 cycle of chemoradiation

Supportive medications:

• Dexamethasone (Decadron) 10 mg PO/IV the day before docetaxel, 30 minutes prior to docetaxel, and the day after docetaxel
• Diphenhydramine (Benadryl) 40 mg IV prior to chemotherapy
• Cimetidine (Tagamet) 40 mg IV prior to chemotherapy
• Granisetron (Kytril) 2 mg IV prior to chemotherapy
• 1.5-2.0 liters fluids before cisplatin

Regimen #2, Day, et al. 2011

Note: The NCCN, Esophageal Cancer version 2.2011, suggests a wider dose range of 20-30 mg/m2 for both cisplatin and docetaxel. The primary reference also investigated these dose levels, but ultimately recommended 30 mg/m2 dosages for both cisplatin and docetaxel.

• Cisplatin (Platinol) 30 mg/m2 IV on days 1, 8, 15, 22, 29
• Docetaxel (Taxotere) 30 mg/m2 IV on days 1, 8, 15, 22, 29
• Concurrent radiation therapy, 2 Gy fractions x 25 fractions, 5 days per week, for a total dose of 50 Gy, to start within 4 hours after the first dose of chemotherapy.

5-week course

Supportive medications:

• "Steroid and anti-emetic pre-medication"

References

1. Li QQ, Liu MZ, Hu YH, Liu H, He ZY, Lin HX. Definitive concomitant chemoradiotherapy with docetaxel and cisplatin in squamous esophageal carcinoma. Dis Esophagus. 2010 Apr;23(3):253-9. Epub 2009 Aug 28. link to original article contains protocol PubMed
2. Day FL, Leong T, Ngan S, Thomas R, Jefford M, Zalcberg JR, Rischin D, McKendick J, Milner AD, Di Iulio J, Matera A, Michael M. Phase I trial of docetaxel, cisplatin and concurrent radical radiotherapy in locally advanced oesophageal cancer. Br J Cancer. 2011 Jan 18;104(2):265-71. Epub 2010 Dec 14. link to original article contains protocol PubMed

Cisplatin (Platinol) & Fluorouracil (5-FU)

Regimen

• Cisplatin (Platinol) 75 mg/m2 IV over 30 minutes on day 1
• Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours on days 1-4
• Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, starting on day 1, for a total dose of 50.4 Gy.

28-day cycles x 2 cycles, THEN

• Cisplatin (Platinol) 75 mg/m2 IV over 30 minutes on day 1
• Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours on days 1-4

28-day cycles x 2 cycles

References

1. Minsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. link to original article contains protocol PubMed

Cisplatin (Platinol) & Irinotecan (Camptosar)

See Cisplatin (Platinol) & Irinotecan (Camptosar) Regimen #1, Ilson, et al. 2011 & Regimen #2, Sharma, et al. 2009.

Cisplatin (Platinol) & Paclitaxel (Taxol)

See Cisplatin (Platinol) & Paclitaxel (Taxol), except patients did not undergo surgery.

Docetaxel (Taxotere) & Capecitabine (Xeloda)

See Docetaxel (Taxotere) & Capecitabine (Xeloda).

Docetaxel (Taxotere) & Fluorouracil (5-FU)

See Docetaxel (Taxotere) & Fluorouracil (5-FU) Regimen #1, Hihara, et al. 2007 & Regimen #2.

FOLFOX 4

FOLFOX: FOLinic acid, Fluorouracil, OXaliplatin

Regimen

Note: In contrast to the original reference, the NCCN, Esophageal Cancer version 2.2011, lists the dosage of leucovorin as 400 mg/m2.

• Fluorouracil (5-FU) 400 mg/m2 IV bolus, then 600 mg/m2/day IV over 22 hours on days 1 & 2; given after Oxaliplatin (Eloxatin) and Folinic acid (Leucovorin)
• Folinic acid (Leucovorin) 200 mg/m2 IV over 2 hours on day 1
• Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours on day 1
• Concurrent radiation therapy, 2 Gy fractions x 25 fractions given 5 days per week, for a total dose of 50 Gy

14-day cycles x 3 cycles, THEN

• Fluorouracil (5-FU) 400 mg/m2 IV bolus, then 600 mg/m2/day IV over 22 hours on days 1 & 2; given after Oxaliplatin (Eloxatin) and Folinic acid (Leucovorin)
• Folinic acid (Leucovorin) 200 mg/m2 IV over 2 hours on day 1
• Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours on day 1

14-day cycles x 3 cycles

References

1. Conroy T, Yataghène Y, Etienne PL, Michel P, Senellart H, Raoul JL, Mineur L, Rives M, Mirabel X, Lamezec B, Rio E, Le Prisé E, Peiffert D, Adenis A. Phase II randomised trial of chemoradiotherapy with FOLFOX4 or cisplatin plus fluorouracil in oesophageal cancer. Br J Cancer. 2010 Oct 26;103(9):1349-55. Epub 2010 Oct 12. link to original article contains protocol PubMed

Oxaliplatin (Eloxatin) & Capecitabine (Xeloda)

See Oxaliplatin (Eloxatin) & Capecitabine (Xeloda).

Oxaliplatin (Eloxatin), Docetaxel (Taxotere), Capecitabine (Xeloda)

See Oxaliplatin (Eloxatin), Docetaxel (Taxotere), Capecitabine (Xeloda).

Oxaliplatin (Eloxatin) & Fluorouracil (5-FU)

See Oxaliplatin (Eloxatin) & Fluorouracil (5-FU) Regimen #1, Lorenzen, et al. 2008. Note: Regimen #1 was a neoadjuvant regimen, but is also listed under definitive chemoradiation by the NCCN, Esophageal Cancer version 2.2011. See Oxaliplatin (Eloxatin) & Fluorouracil (5-FU) Regimen #2, Khushalani, et al. 2002.

Paclitaxel (Taxol) & Capecitabine (Xeloda)

See Paclitaxel (Taxol) & Capecitabine (Xeloda).