Pancreatic Adenocarcinoma Treatment Regimens

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PANCREATIC ADENOCARCINOMA TREATMENT REGIMENS

(Revised 2/2017)

© 2017 Haymarket Media, Inc.

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 health care 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 pancreatic adenocarcinoma cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These pancreatic adenocarcinoma 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 become 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.

Metastatic Disease1

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

Good Performance Status

REGIMEN

DOSING

FOLFIRINOX (oxaliplatin + irinotecan + 5-fluorouracil [5-FU]/leucovorin) (Category 1) (preferred)2

Day 1: Oxaliplatin 85mg/m2 IV + irinotecan 180mg/m2 IV + leucovorin 400mg/m2 IV, followed by a 5-FU bolus of 400mg/m2 and a 46-hour continuous 5-FU infusion of 2,400mg/m2.

Repeat cycle every 2 weeks until disease progression.

Gemcitabine + Albumin-bound Paclitaxel (Category 1) (preferred)3

Days 1, 8, and 15: Nab-paclitaxel 125mg/m2 IV + gemcitabine 1,000mg/m2 IV.

Repeat cycle every 4 weeks until disease progression.

Gemcitabine + Erlotinib (Category 1)4

Cycle 1 (8-week cycle):

Days 1, 8, 15, 22, 29, 36, and 43: Gemcitabine 1,000mg/m2 IV follow by a 1-week rest

Days 1–56: Erlotinib 100mg orally daily, followed by:

Subsequent cycles (4-week cycle):

Days 1, 8, and 15: Gemcitabine 1,000mg/m2 IV over 30 minutes

Days 1–28: Erlotinib 100mg orally daily.

Gemcitabine + Capecitabine5

Days 1, 8, and 15: Gemcitabine 1,000mg/m2 IV

Days 1–21: Capecitabine 1,660mg/m2 orally daily (830mg/m2 twice daily).

Repeat cycle every 4 weeks until disease progression.

Gemcitabine + Cisplatin6

Days 1 and 15: Gemcitabine 1,000mg/m2 IV + cisplatin 50mg/m2 IV.

Repeat cycle every 4 weeks until disease progression.

GTX (Fixed-dose rate gemcitabine + docetaxel + capecitabine) (Category 2B)7

Days 1–14: Capecitabine 750mg/m2 orally twice daily

Days 4 and 11: Gemcitabine 750mg/m2 IV + docetaxel 30mg/m2 IV.

Repeat cycle every 21 days until disease progression.

Fluoropyrimidine (5-FU + leucovorin or capecitabine) + Oxaliplatin (Category 2B)8,9

Days 1, 8, 15, and 22: Leucovorin 200mg/m2 IV followed by 5-FU 2g/m2 continuous IV infusion over 24 hours

Days 8 and 22: Oxaliplatin 85mg/m2 IV.

After a rest of 3 weeks, repeat cycle on day 43.

OR

Age ≤ 65 years and ECOG performance status 0 to 1:

Day 1: Oxaliplatin 130mg/m2 IV

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

Repeat cycle every 3 weeks.

Age > 65 years and ECOG performance status 2:

Day 1: Oxaliplatin 110mg/m2 IV

Days 1–14: Capecitabine 750mg/m2 orally twice daily.

Repeat cycle every 3 weeks.

Poor Performance Status

Gemcitabine (Category 1)1

Days 1, 8, and 15: Gemcitabine 1,000mg/m2 IV over 30 minutes.

Repeat cycle every 28 days.

Fixed-dose Rate Gemcitabine (Category 2B)1

Days 1, 8, and 15: Gemcitabine 10mg/m2/minute IV.

Repeat cycle every 28 days.

Capecitabine (Category 2B)1

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

Repeat cycle every 3 weeks for up to 52 weeks.

Continuous Infusion 5-FU (Category 2B)10

Days 1–28: Fluorouracil 250mg/m2 continuous IV infusion over 24 hours.

Repeat each 42-day cycle until disease progression or unacceptable toxicity.

Second-Line Therapy1

Principles of Chemotherapy:

• Second-line chemotherapy may consist of:

○ 5-FU + leucovorin + liposomal irinotecan (Category 1) for metastatic disease previously treated with gemcitabine-based therapy11

○ Gemcitabine-based therapy for those previously treated with fluoropyrimidine-based therapy

○ Fluoropyrimidine-based therapy for those previously treated with gemcitabine-based therapy

Locally Advanced Disease1

Principles of Chemotherapy:

• Depending on performance status, mono- or combination systemic chemotherapy may be considered as initial therapy prior to chemoradiation for appropriate patients with locally advanced, unresectable disease.

• Patients should be evaluated for recovery from hematologic and nonhematologic toxicity prior to initiation of chemoradiation.

Patients who progress with metastatic disease are not candidates for chemoradiation unless required for palliative purposes.

Adjuvant Treatment

Gemcitabine (Category 1)12

Days 1, 8, and 15: Gemcitabine 1,000mg/m2 IV over 30 minutes.

Repeat cycle every 28 days.

5-FU + Leucovorin (Category 1)13

Days 1–5: Leucovorin 20mg/m2 IV bolus, followed by 5-FU 425mg/m2 IV bolus.

Repeat cycle every 4 weeks.

Gemcitabine + Radiation10

Prior to chemoradiation:

Days 1, 8 and 15: Gemcitabine 1,000mg/m2 IV; initiate 1–2 weeks prior to chemoradiation (50.4Gy + 5-FU 250mg/m2/day).

After chemoradiation:

Days 1, 8 and 15: Gemcitabine 1,000mg/m2 IV; initiate 3–5 weeks following chemoradiation.

Repeat cycle every 4 weeks for 3 months.

Continuous infusion 5-FU + Radiation10

Prior to chemoradiation:

Days 1–21: 5-FU 250mg/m2/day continuous IV infusion; initiate 1–2 weeks prior to chemoradiation (50.4Gy + 5-FU 250mg/m2/day).

After chemoradiation:

Days 1–28: 5-FU 250mg/m2/day continuous IV infusion; initiate 3–5 weeks following chemoradiation.

Repeat cycle every 6 weeks for 3 months.

Capecitabine (Category 2B)14

Days 1–14: Capecitabine 825-1,000mg/m2 orally twice daily.

Repeat cycle every 3 weeks for up to 52 weeks.

Principles of Chemotherapy:

• The CONKO-001 trial demonstrated significant improvements in disease-free survival and overall survival with use of postoperative gemcitabine as adjuvant chemotherapy versus observation in resectable pancreatic adenocarcinoma.12

• ESPAC-3 study results showed no significant difference in overall survival between 5-FU/leucovorin versus gemcitabine following surgery. When the groups receiving adjuvant 5-FU/leucovorin and adjuvant gemcitabine were compared, median survival was 23.0 months and 23.6 months, respectively.13

• The use of gemcitabine-based chemotherapy is frequently combined, sequentially, with 5-FU-based chemoradiotherapy.

No significant differences were observed in the RTOG 97-04 study comparing pre- and post-chemoradiation 5-FU with pre- and post-chemoradiation gemcitabine for postoperative adjuvant treatment.10

• For patients with good performance status who relapse after receiving adjuvant therapy, FOLFIRINOX or gemcitabine + albumin-bound paclitaxel are options depending on the length of time since completion of adjuvant therapy.

• Recommended adjuvant therapy options apply to patients who did not receive prior neoadjuvant therapy. For those who received prior neoadjuvant therapy, the adjuvant therapy options are dependent on the response to neoadjuvant therapy and other clinical considerations.

Neoadjuvant Therapy1

Principles of Chemotherapy:

• There is limited evidence to recommend specific neoadjuvant regimens off-study, and practices vary with regard to the use of chemotherapy and chemoradiation. Acceptable regimens include FOLFIRINOX or gemcitabine + albumin-bound paclitaxel. Subsequent chemoradiation is sometimes included.

References

1. Referenced with permission from NCCN Clinical Practice Guidelines in Oncology™. Pancreatic Adenocarcinoma. v 2.2016. Available at: http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed January 30, 2017.

2. Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364:1817–1825.

3. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369:1691–1703.

4. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007;25:1960–1966.

5. Cunningham D, Chau I, Stocken D D, et al. Phase III randomized comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. J Clin Oncol. 2009; 27:5513–5518.

6. Oliver GR, Sugar E, Laheru D, et al. Family history of cancer and sensitivity to platinum chemotherapy in pancreatic adenocarcinoma [abstract]. Presented at: 2010 ASCO Gastrointestinal Cancers Symposium; January 22–24, 2010; Orlando, Florida. Abstract 180.

7. Fine RL, Fogelman DR, Schreibman SM, et al. The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis. Cancer Chemother Pharmacol. 2008;61:167–175.

8. Pelzer U, Schwaner I, Stieler J, et al. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011;47:1676–1681.

9. Xiong HQ, Varadhachary GR, Blais JC, et al. A phase ll trial of oxaliplatin plus capecitabine (xelox) as second-line therapy for patients with advanced pancreatic cancer. Cancer. 2008;113:2046–2052.

10. Regine, WF Winter KA, Abrams RA et al. Fluorouracil vs. gemcitabine chemotherapy before and after fluorouracil-based chemoradiation after resection of pancreatic adenocarcinoma. A randomized controlled trial. JAMA. 2008; 299:1019–1026.

11. Wang-Gillam A, Li CP, Bodoky G, et al. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016; 387(10018):545–547.

12. Oettle H, Neuhaus P, Hochhaus A, et al. Adjuvant Chemotherapy With Gemcitabine and Long-term Outcomes Among Patients With Resected Pancreatic Cancer: The CONKO-001 Randomized Trial. JAMA. 2013;310(14):1473–1481.

13. Neoptolemos J, Buchler M, Stocken DD, Bassi C, et al. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010;304:1073–1081.

14. Twelves C, Wong A, Nowacki MP, et al. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005;352(26):2696–704.


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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