Esophageal and Esophagogastric Junction Cancer Treatment Regimens

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ESOPHAGEAL AND ESOPHAGOGASTRIC JUNCTION
CANCER TREATMENT REGIMENS

Clinical Trials: The 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 esophageal and esophagogastric junction cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These esophageal and esophagogastric junction cancer treatment regimens are provided only to supplement the latest treatment strategies.

These Cancer Treatment 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 National Comprehensive Cancer Network 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.

Preoperative Chemoradiation1

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

Preferred Regimens

REGIMEN

DOSING

Paclitaxel + carboplatin (Category 1)2

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

Repeat weekly for 5 weeks (Days 1, 8, 15, 22, and 29).

Cisplatin + 5-fluorouracil (5-FU) (Category 1)3,4

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

Days 1–4 and 29–32: 5-FU 750–1,000mg/m2 IV continuous infusion over 24 hours on a 35-day cycle.

OR

Days 1–5: Cisplatin 15mg/m2 IV daily

Days 1–5 and Days 22–26: 5-FU 800 mg/m2 IV continuous infusion over 24 hours.

Cycled every 21 days for 2 cycles.

Oxaliplatin + 5-FU + leucovorin5

Day 1: Oxaliplatin 85mg/m2 and leucovorin 200mg/m2 followed by 5-FU 400mg/m2 bolus, then 1,600mg/m2 46-hour continuous infusion; the first 3 cycles were delivered during radiotherapy (RT), the other 3 after RT for 6 bimonthly (14 days) cycles.

Cisplatin + capecitabine (Category 1)6

Day 1: Cisplatin 30mg/m2 IV

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

Repeat cycle weekly for 5 weeks.

Oxaliplatin + 5-FU (Category 1)7

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

Days 1–33: 5-FU 180mg/m2/day continuous IV infusion.

Oxaliplatin + capecitabine (Category 1)8

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

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

Other Regimens

Irinotecan + cisplatin (Category 2B)9

Days 1, 8, 22, and 29: Irinotecan 65mg/m2 IV plus cisplatin 30mg/m2 IV.

Paclitaxel + 5-FU (Category 2B)10

Day 1: Paclitaxel 45mg/m2 IV weekly

Days 1–5: 5-FU 300mg/m2/day continuous IV infusion.

Repeat cycle weekly for 5 weeks.

Paclitaxel + capecitabine (Category 2B)10

Day 1: Paclitaxel 45–50mg/m2 IV

Days 1–5: Capecitabine 625–825mg/m2 orally twice daily.

Repeat cycle weekly for 5 weeks.

Perioperative Chemotherapy (including esophagogastric junction)1

ECF (epirubicin + cisplatin + 5-FU) (Category 3)11a

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

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

Repeat cycle every 21 days for 3 cycles preoperatively and 3 cycles postoperatively.

ECF modifications (Category 3)12

Day 1: Epirubicin 50mg/m2 IV; cisplatin 60mg/m2 IV

Days 1–21: 5-FU 200mg/m2 IV continuous infusion once daily; cycled every 21 days for 3 cycles preoperatively and 3 cycles postoperatively.

OR

Day 1: Epirubicin 50mg/m2 IV; oxaliplatin 130mg/m2 IV

Days 1–21: 5-FU 200mg/m2 IV continuous infusion over 24 hours; cycled every 21 days for 3 cycles preoperatively and 3 cycles postoperatively.

OR

Day 1: Epirubicin 50mg/m2 IV; oxaliplatin 130mg/m2 IV

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

Cycled every 21 days for 3 cycles preoperatively and 3 cycles postoperatively.

5-FU + cisplatin (Category 1)13

Day 1: Cisplatin 100mg/m2 IV

Days 1–5: 5-FU 800mg/m2 IV continuous infusion over 24 hours daily; cycled every 28 days for 2–3 cycles preoperatively and 3-4 cycles postoperatively for a total of 6 cycles.

Definitive Chemoradiation (Nonsurgical)1

Preferred Regimens

Cisplatin + 5-FU (Category 1)14

Day 1: Cisplatin 75–100mg/m2 IV

Days 1–4: 5-FU 750–1,000mg/m2/day continuous IV infusion over 24 hours daily.

Repeat cycle every 28 days for 2–4 cycles for 2 cycles with radiation followed by 2 cycles without radiation.

Oxaliplatin + 5-FU (Category 1)7,15

Days 1, 15, and 29: Oxaliplatin 85mg/m2 IV for 3 doses

Days 1–33: 5-FU 180mg/m2 IV daily.

OR

Day 1: Oxaliplatin 85mg/m2 IV

Day 1: Leucovorin 400mg/m2 IV

Day 1: 5-FU 400mg/m2 IVP

Days 1 and 2: 5-FU 800mg/m2 continuous IV over 24 hours daily.

Repeat cycle every 14 days for 3 cycles with radiation followed by 3 cycles without radiation.

Cisplatin + capecitabine (Category 1)6

Day 1: Cisplatin 30mg/m2 IV

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

Repeat cycle weekly for 5 weeks.

Oxaliplatin + capecitabine (Category 1)8

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

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

Paclitaxel + carboplatin2

Day 1: Paclitaxel 50mg/m2 IV and carboplatin 2mg·min/mL IV once weekly for 5 weeks.

Other Regimens

Paclitaxel + cisplatin16

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

Day 1: Cisplatin 75mg/m2 IV given for 1 cycle.

Docetaxel + cisplatin17,18

Days 1 and 22: Docetaxel 60mg/m2 IV

Days 1 and 22: Cisplatin 60–80mg/m2 IV given for 1 cycle.

OR

Day 1: Docetaxel 20–30mg/m2 IV

Day 1: Cisplatin 20–30mg/m2 IV given for weekly for 5 weeks.

Irinotecan + cisplatin (Category 2B)9

Days 1, 8, 22, and 29: Irinotecan 65mg/m2 IV

Days 1, 8, 22, and 29: Cisplatin 30mg/m2 IV.

Paclitaxel + 5-FU (Category 2B)10

Day 1: Paclitaxel 45mg/m2 IV weekly

Days 1–5: 5-FU 300mg/m2 IV continuous infusion daily.

Repeat cycle weekly for 5 weeks.

Paclitaxel + capecitabine (Category 2B)10

Day 1: Paclitaxel 45–50mg/m2 IV

Days 1–5: Capecitabine 625–825mg/m2 PO twice daily.

Repeat cycle weekly for 5 weeks.

Postoperative Chemoradiation (for adenocarcinoma or gastroesophageal junction only)1

5-FU + leucovorin (Category 1)18,19

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.

NOTE: The NCCN panel acknowledges that the Intergroup 0116 Trial formed the basis for postoperative adjuvant chemoradiation strategy. However, the panel does not recommend the above specified doses or schedule of cytotoxic agents because of concerns regarding toxicity. The panel recommends one of the following modifications instead:

Capecitabine20,21

Days 1–14: Capecitabine 750–1000mg/m2 orally twice daily; cycled every 28 days; 1 cycle before and 2 cycles after chemoradiation.

5-FU + leucovorin22

Days 1, 2, 15, and 16: Leucovorin 200mg/m2 IV as 2-hour infusion followed by 5-FU 400mg/m2 IV push and a 22-hour infusion of 5-FU 600mg/m2.

5-FU with radiation23

Days 1–5 OR Days 1–7: 5-FU 200–250mg/m2 IV continuous infusion over 24 hours daily, once weekly for 5 weeks.

Capecitabine with radiation6

Days 1–5 OR Days 1–7: Capecitabine 625–825mg/m2 orally twice daily, once weekly for 5 weeks.

Metastatic or Locally Advanced Cancer (where local therapy is not indicated)1

First-line therapy

Trastuzumab + chemotherapy (for HER2-neu malignancies)24

Day 1: Trastuzumab 8mg/kg IV loading dose (Cycle 1 only); followed by trastuzumab 6mg/kg IV every 3 weeks, plus chemotherapy (Category 2B).

OR

Day 1 of Cycle 1: Trastuzumab 6mg/kg IV loading dose, then 4mg/kg IV every 14 days

Day 1: Cisplatin 80mg/m2 IV, plus

Days 1–14: Capecitabine 1000mg/m2 orally twice daily OR Days 1–5: 5-FU 800mg/m2 continuous IV infusion (Category 1).

Repeat cycle every 21 days for 6 cycles.

Preferred Regimens

DCF (docetaxel +

leucovorin + cisplatin + 5-FU)25

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

Days 1 and 2: 5-FU 1000mg/m2 IV continuous infusion over 24 hours (total 2000mg/m2), followed by

Day 3: Cisplatin 40mg/m2 IV.

Repeat cycle every 14 days.

Modified DCF (docetaxel + oxaliplatin + leucovorin + 5-FU)26

Day 1: Docetaxel 50mg/m2 IV + leucovorin 200mg/m2 IV + oxaliplatin 85mg/m2 IV + 5-FU 2600mg/m2 IV continuous infusion over 24 hours.

Repeat cycle every 14 days.

Modified DCF (docetaxel + oxaliplatin + 5-FU)27

Day 1: Docetaxel 50mg/m2 IV + oxaliplatin 85mg/m2 IV

Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours.

Repeat cycle every 14 days.

Modified DCF (docetaxel + carboplatin + 5-FU) (Category 2B)28

Day 1: Docetaxel 75mg/m2 IV

Day 2: Carboplatin AUC 6mg·min/mL IV

Days 1–3: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily.

Repeat cycle every 21 days.

Fluoropyrimidine and cisplatin (5-FU + cisplatin) (Category 1)29b

Day 1: Cisplatin 100mg/m2 IV

Days 1–4: 5-FU 1,000mg/m2 IV continuous infusion over 24 hours daily doses of 250mg/m2 IV over 60 minutes.

Fluoropyrimidine and cisplatin (5-FU + cisplatin + leucovorin) (Category 1)26,30b

Day 1: Cisplatin 50mg/m2 IV

Day 1: Leucovorin 200mg/m2 IV

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

Repeat cycle every 14 days.

Fluoropyrimidine and cisplatin (capecitabine + cisplatin) (Category 1)31

Day 1: Cisplatin 80mg/m2 IV

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

Repeat cycle every 3 weeks

Fluoropyrimidine and oxaliplatin

(oxaliplatin + leucovorin +

5-FU)31,32

Day 1: Oxaliplatin 85mg/m2 IV plus leucovorin 400mg/m2 IV plus 5-FU 400mg/m2 IVP

Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily.

Repeat cycle every 14 days.

OR

Day 1: Oxaliplatin 85mg/m2 IV plus leucovorin 200mg/m2 IV plus 5-FU 400mg/m2IVP plus 5-FU 2600mg/m2 IV continuous infusion over 24 hours daily.

Repeat cycle every 14 days.

Fluoropyrimidine and oxaliplatin (oxaliplatin + capecitabine)33

Day 1: Oxaliplatin 130mg/m2 IV

Days 1–14: Capecitabine 1000mg/m2 orally twice daily.

Repeat cycle every 21 days.

Other Regimens

Paclitaxel + cisplatin or carboplatin34–36

Day 1: Paclitaxel 135–200mg/m2 IV

Day 2: Cisplatin 75mg/m2 IV

Repeat cycle every 21 days.

OR

Day 1: Paclitaxel 90mg/m2 IV plus cisplatin 75mg/m2 IV

Repeat cycle every 14 days.

OR

Day 1: Paclitaxel 200mg/m2 IV plus carboplatin 5mg·min/mL.

Repeat cycle every 21 days.

Docetaxel + cisplatin37,38

Day 1: Docetaxel 70–85mg/m2 IV plus cisplatin 70–75mg/m2 IV.

Repeat cycle every 21 days.

Docetaxel + irinotecan (Category 1)39

Days 1 and 8: Docetaxel 35mg/m2 IV plus irinotecan 50mg/m2 IV.

Repeat cycle every 21 days.

Fluoropyridimine40-42

Day 1: Leucovorin 400mg/m2 IV plus 5-FU 400mg/m2 IVP

Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily.

Repeat cycle every 14 days.

OR

Days 1–5: 5-FU 800mg/m2 IV continuous infusion over 24 hours daily.

Repeat cycle every 28 days.

OR

Days 1–14: Capecitabine 1000–1250mg/m2 orally twice daily.

Repeat cycle every 21 days.

Taxane43–45

Day 1: Docetaxel 75–100mg/m2 IV.

Repeat cycle every 21 days.

OR

Day 1: Paclitaxel 135–250mg/m2 IV.

Repeat cycle every 21 days.

OR

Days 1, 8, 15, and 22: Paclitaxel 80mg/m2 IV once weekly.

Repeat cycle every 28 days.

ECF (epirubicin + cisplatin + 5-FU) (Category 1)46,47

Day 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 21 days.

ECF modifications (epirubicin + oxaliplatin + 5-FU) (Category 1)47

Days 1: Epirubicin 50mg/m2 IV + oxaliplatin 130mg/m2 IV

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

Repeat cycle every 21 days.

ECF modifications (epirubicin + cisplatin + capecitabine) (Category 1)47

Day 1: Epirubicin 50mg/m2 IV + cisplatin 60mg/m2 IV

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

Repeat cycle every 21 days.

ECF modifications (epirubicin + oxaliplatin + capecitabine) (Category 1)47

Day 1: Epirubicin 50mg/m2 IV + oxaliplatin 130mg/m2 IV

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

Repeat cycle every 21 days.

5-FU and irinotecan (irinotecan + leucovorin + 5-FU) (Category 1)40,48,49

Day 1: Irinotecan 80mg/m2 IV + leucovorin 500mg/m2 IV + 5-FU 2000mg/m2 IV continuous infusion over 24 hours, weekly for 6 weeks followed by 1 week off treatment Or weekly for 6 weeks followed by 2 weeks off treatment.

OR

Day 1: Irinotecan 180mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IVP

Day 1–2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours.

Repeat cycle every 14 days.

Second-line Therapy1

Preferred Regimens

Ramucirumab + paclitaxel (for adenocarcinoma) (Category 1 for EGJ adenocarcinoma; Category 2A for esophageal adenocarcinoma)50

Days 1 and 15: Ramucirumab 8mg/kg IV

Days 1, 8, and 15: Paclitaxel 80mg/m2 IV.

Repeat cycle every 28 days.

Ramucirumab (for adenocarcinoma) (Category 1 for EGJ adenocarcinoma; Category 2A for esophageal adenocarcinoma)51

Days 1 and 15: Ramucirumab 8mg/kg IV.

Repeat cycle every 28 days.

Docetaxel (Category 1)43

Day 1: Docetaxel 75–100mg/m2 IV

Repeat cycle every 21 days.

Paclitaxel (Category 1)43,44,52

Day 1: Paclitaxel 135–250mg/m2 IV

Repeat cycle every 21 days.

OR

Day 1: Paclitaxel 80mg/m2 IV once weekly

Repeat cycle every 28 days.

OR

Days 1, 8, and 15: Paclitaxel 80 mg/m2 IV.

Repeat cycle every 28 days.

Irinotecan (Category 1)52–54

Day 1: Irinotecan 250–350mg/m2 IV

Repeat cycle every 21 days.

OR

Day 1: Irinotecan 150–180mg/m2 IV

Repeat cycle every 14 days.

OR

Days 1 and 8: Irinotecan 125mg/m2 IV.

Repeat cycle every 21 days.

Irinotecan + cisplatin32,55

Days 1 and 8: Irinotecan 65mg/m2 IV plus cisplatin 25–30mg/m2 IV.

Repeat cycle every 21 days.

Irinotecan + fluoropyridimine (Category 2B)56

Day 1: Irinotecan 250mg/m2 IV

Days 1–14: Capecitabine 1000mg/m2 PO BID daily.

Repeat cycle every 21 days.

Irinotecan + fluoropyridimine (Category 2B)48,57

Day 1: Irinotecan 180mg/m2 IV plus leucovorin 400mg/m2 IV plus 5-FU 400mg/m2 IVP

Days 1 and 2: 5-FU 600–1200mg/m2/day IV continuous infusion on days 1 and 2.

Repeat cycle every 14 days.

Docetaxel + irinotecan (Category 2B)39

Days 1 and 8: Docetaxel 35mg/m2 IV plus irinotecan 50mg/m2 IV.

Repeat cycle every 21 days.

Second-line Therapy1

General Treatment Notes1

Chemotherapy regimens should be chosen in the context of performance status, medical comorbidities, toxicity profile, and HER2-neu expression (for adenocarcinoma only). Two-drug cytotoxic regimens are preferred for patients with advanced disease because of lower toxicity, Three-drug cytotoxic regimens should be reserved for medically fit patients with good PS and access to frequent toxicity evaluation. Doses and schedules for any regimen that is not derived from category 1 evidence is a suggestion, and subject to appropriate modifications depending on the circumstances, Infusional fluorouracil and capecitabine may be used interchangeably (except as indicated). Cisplatin and oxaliplatin may be used interchangeably depending on toxicity profile.

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

b May be coupled with cetuximab administered as an initial dose of cetuximab 400 mg/m2 IV on Day 1 over 120 minutes; followed by weekly doses of 250 mg/m2 IV over 60 minutes.

References

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(Revised 9/2016)

© 2016 Haymarket Media, Inc.


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 MPR.

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