Gastric Cancer Treatment Protocols: General Treatment Recommendations, Neoadjuvant Chemoradiotherapy Regimens, Perioperative Chemotherapy Regimens

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Sections Gastric Cancer Treatment Protocols
General Treatment Recommendations
Neoadjuvant Chemoradiotherapy Regimens
Perioperative Chemotherapy Regimens
Postoperative Chemoradiotherapy Regimens
Postoperative Chemotherapy Regimens
First-Line Chemotherapy for Metastatic or Locally Advanced Cancer (Where Local Therapy Not Indicated)
Second-Line Chemotherapy for Metastatic or Locally Advanced Cancer (Where Local Therapy Not Indicated)
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References

General Treatment Recommendations

Tumors involving the esophagogastric junction (EGJ) with the tumor epicenter no more than 2 cm into the proximal stomach are staged as esophageal cancers, while EGJ tumors with their epicenter located more than 2 cm into the proximal stomach are staged as stomach cancers, as are all cardia cancers not involving the EGJ.

Treatment decisions should be made with a multidisciplinary team^[1] and based on the following:

Stage of disease
Surgical fitness of the patient
The patient’s preference
Patient comorbidities

Stage 0 to IA

Surgery is the primary treatment for early-stage gastric cancer. Complete surgical resection offers the potential for long-term survival.

Laparoscopic resection is an emerging modality that may improve operative mortality, but requires additional investigation.^[2]Endoscopic mucosal resection and endoscopic submucosal dissection should be performed only in experienced medical centers.^[1]

Stage IB to IIIC, potentially resectable

For medically fit patients, perioperative neoadjuvant chemotherapy or chemoradiotherapy followed by surgery is appropriate. Perioperative therapy is common practice, with chemoradiotherapy after surgery showing a clear survival benefit in patients who did not receive preoperative chemotherapy^[3]. For patients who received preoperative chemotherapy, the addition of postoperative radiotherapy has not demonstrated additional benefit.^[4]

Medically unfit patients can be treated with chemoradiotherapy or chemotherapy.

Stage IV

Chemotherapy based around a doublet or triplet platinum/fluoropyrimidine combination is given for metastatic disease. Local therapy is not indicated. HER2 and PD-L1 testing are recommended upon confirmation of metastatic disease.^{[1, 5]}

Trastuzumab should be added to first-line chemotherapy in HER2-NEU overexpressing metastatic adenocarcinomas.^{[6, 5]}

Preferred regimens

A higher level of evidence supports use of the following regimens; clinical trials have shown strong benefit and there is consensus among experts^[1]:

Paclitaxel 50 mg/m² IV on day 1 plus carboplatin AUC 2 IV on day 1; weekly for 5 wk^{[7, 8]}(see the Carboplatin AUC Dose Calculation [Calvert formula] calculator)or
Cisplatin 75-100 mg/m² IV on day 1 plus 5-fluorouracil (5-FU) 750-1000 mg/m²/day IV continuous infusion on days 1-4 and 29-32; single 35-day cycle^[9] or
Cisplatin 30 mg/m² IV on day 1 plus capecitabine 800 mg/m² PO BID on days 1-5; weekly for 5wk^[10] or
Cisplatin 15 mg/m² IV daily on days 1-5 and days 22-26 plus 5-FU 800 mg/m²/day IV continuous infusion on days 1-5 and days 22-26; single 35-day cycle^[11] or
Oxaliplatin 85 mg/m² IV on days 1, 15, and 29 plus capecitabine 625 mg/m² PO BID on days 1-5, 8-12, 15-19, 22-26, and 29-33; single 35-day cycle^[12]or
Oxaliplatin 85 mg/m² on days 1, 15, and 29 plus 5-FU 180 mg/m² continuous IV infusion daily on days 1-33^[13] or
Oxaliplatin 85 mg/m² IV on day 1 plus leucovorin 400 mg/m² IV on day 1 plus 5-FU 400 mg/m² IVP on day 1 and 5-FU 800 mg/m² continuous IV infusion daily on days 1 and 2; every 14 d for three cycles with radiation and three cycles after radiation^[14]

Other regimens

A lower level of evidence supports use of the following regimens; smaller studies show benefit of the therapy, and therapy may need to be used on the basis of the clinical situation (eg, limiting toxicities, patient comorbidity)^[1]:

Oxaliplatin 45-50 mg/m² IV on day 1 weekly for 5 wk plus 5-FU 225 mg/m² IV daily on days 1-33; single 35-day cycle^[15] or
Carboplatin AUC 6 IV on days 1 and 22 plus 5-FU 200 mg/m² IV daily on days 1-42^[16] or
Irinotecan 65 mg/m² IV on days 1, 8, 22, and 29 plus cisplatin 30 mg/m² IV on days 1, 8, 22, and 29^[17]or
Paclitaxel 45-50 mg/m² IV on day 1 plus 5-FU 300 mg/m² continuous IV infusion daily on days 1-5; weekly for 5 wk^[18] or
Paclitaxel 45-50 mg/m² IV on day 1 plus capecitabine 625-825 mg/m² PO BID daily on days 1-5; weekly for 5 wk^{[18, 19]}

Perioperative Chemotherapy Regimens

The following regimens consist of three cycles before surgery and three cycles after surgery; the following regimens are used only for adenocarcinoma of the distal esophagus or gastroesophageal junction^[1] ("ECF" regimen and variants):

Epirubicin 50 mg/m² IV on day 1 plus cisplatin 60 mg/m² IV on day 1 plus 5-FU 200 mg/m²/day IV continuous infusion daily for days 1-21; every 21 d for six cycles—three preoperatively and three postoperatively^[3] or
Epirubicin 50 mg/m² IV on day 1 plus oxaliplatin 130 mg/m² IV on day 1 plus 5-FU 200 mg/m²/day IV continuous infusion daily for days 1-21; every 21 d for six cycles—three preoperatively and three postoperatively^[20] or
Epirubicin 50 mg/m² IV on day 1 plus cisplatin 60 mg/m² IV on day 1 plus capecitabine 625 mg/m² PO BID daily for days 1-21; every 21 d for six cycles—three preoperatively and three postoperatively^[20] or
Epirubicin 50 mg/m² IV on day 1 plus oxaliplatin 130 mg/m² IV on day 1 plus capecitabine 625 mg/m² PO BID daily for days 1-21; every 21 d for six cycles—three preoperatively and three postoperativelyy^[20] or

See the list below:

Cisplatin 75-80 mg/m ² IV on day 1 plus 5-FU 800 mg/m ² continuous IV infusion on days 1-5; every 28 d; two or three cycles preoperatively and three or four cycles postoperatively for a total of six cycles ^[21]

The following regimen consists of four 14-day cycles preoperatively and then adjuvant therapy with the same regimen ("FLOT" regimen):

5-FU 2600 mg/m ² IV plus folinic acid 200 mg/m ² plus oxaliplatin 85 mg/m ² plus docetaxel 50 mg/m ² ^[22]

Postoperative Chemoradiotherapy Regimens

Uses of the following postoperative chemoradiotherapy regimens include cancers of the gastroesophageal junction:

Leucovorin 20 mg/m² IVP on days 1-5 plus 5-FU 425 mg/m² IVP daily on days 1-5, every 28 d (cycles 1, 3, and 4 given before and after radiation); for cycle 2, give leucovorin 20 mg/m² IVP on days 1-4 and 31-33 plus 5-FU 400 mg/m² IVP daily on days 1-4, every 35 d (cycle 2 given with radiation)^[23]

Note: The National Comprehensive Cancer Network (NCCN) panel does not recommend the above specified doses or schedule, because of concerns regarding toxicity; instead, the panel recommends using one of the following modified regimens.^[1]

One cycle before and two cycles after chemoradiation:

Capecitabine 750-1000 mg/m² PO BID on days 1-14; every 28 d (one cycle before and two cycles after chemoradiation)
Leucovorin 400 mg/m² IV on days 1 and 15 or days 1, 2, 15, and 16 plus 5-FU 400 mg/m² IVP on days 1 and 15 or days 1, 2, 15, and 16 and 5-FU 1200 mg/m² continuous IV infusion over 24 h daily on days 1, 2, 15 and 16, every 14 d (one cycle before radiation and two cycles after radiation)^[24]

With radiation:

5-FU 200-250 mg/m²/day continuous IV infusion on days 1-5 or 1-7; weekly for 5 wk^[25] or
Capecitabine 625-825 mg/m² PO BID daily for days 1-5 or 1-7; weekly for 5 wk^[26]

Postoperative Chemotherapy Regimens

Postoperative chemotherapy regimens for patients who underwent D2 lymph node dissection include the following:

Oxaliplatin 130 mg/m² IV on day 1 plus capecitabine 1000 mg/m² PO BID on days 1-14; every 21 d for eight cycles^[27] or
Cisplatin 60 mg/m² IV on day 1 plus capecitabine 1000 mg/m² PO BID on days 1-14; every 21 d for six cycles^[28]

In one trial, postoperative adjuvant chemotherapy with capecitabine and cisplatin compared with postoperative chemoradiotherapy showed inferior disease-free survival, which may suggest that in patients who have undergone D2 lymph node dissection, chemoradiotherapy may be superior. However, this requires further study.^[29]

Compared with adjuvant chemotherapy, observation postoperatively leads to decreased overall survival.^[30]

Stage IV

For HER2-NEU overexpressing adenocarcinomas, trastuzumab should be added to first-line chemotherapy consisting of cisplatin plus a fluoropyrimidine (eg, 5-FU, capecitabine) but is not recommended in regimens containing an anthracycline.^[1] Trastuzumab is used as follows:

Trastuzumab 8 mg/kg IV loading dose on day 1 of cycle one, then 6 mg/kg IV; every 21 d with chemotherapy^[31] or
Trastuzumab 6 mg/kg IV loading dose on day 1 of cycle one, then 4 mg/kg IV every 14 d with chemotherapy

Preferred regimens^[1]

Two-drug regimens are preferred because of lower toxicity; reserve three-drug regimens for patients who are medically fit and have access to frequent follow-up:

Docetaxel 75 mg/m² IV on day 1 plus cisplatin 75 mg/m² IV on day 1 plus 5-FU 1000 mg/m²/day continuous IV infusion on days 1-5; every 28 d^[32]

Note that the NCCN panel does not recommend the above specified doses or schedule because of concerns regarding toxicity, and instead suggests using one of the following modified regimens:

Docetaxel 40 mg/m² IV on day 1 plus leucovorin 400 mg/m² IV on day 1 plus 5-FU 400 mg/m² IV on day 1 plus 5-FU 1000 mg/m²/day continuous IV infusion on days 1 and 2 plus cisplatin 40 mg/m² IV on day 3; every 14 d^[33] or
Docetaxel 50 mg/m² IV on day 1 plus oxaliplatin 85 mg/m² IV on day 1 plus 5-FU 1200 mg/m²/day continuous IV infusion on days 1 and 2; every 14 d^[34] or
Docetaxel 75 mg/m² IV on day 1 plus carboplatin AUC 6 IV on day 2 plus 5-FU 1200 mg/m²/day continuous IV infusion on days 1-3; every 21 d^[35] or
Epirubicin 50 mg/m² IV on day 1 plus cisplatin 60 mg/m² IV on day 1 plus 5-FU 200 mg/m²/day continuous IV infusion on days 1-21; every 21 d^{[36, 37]} or
Epirubicin 50 mg/m² IV on day 1 plus oxaliplatin 130 mg/m² on day 1 plus 5-FU 200 mg/m²/day continuous IV infusion on days 1-21; every 21 d^[37] or
Epirubicin 50 mg/m² IV on day 1 plus cisplatin 60 mg/m² IV on day 1 plus capecitabine 625 mg/m² PO BID daily on days 1-21; every 21 d^[37] or
Epirubicin 50 mg/m² IV on day 1 plus oxaliplatin 130 mg/m² IV on day 1 plus capecitabine 625 mg/m² PO BID daily on days 1-21; every 21 d^[37] or
Cisplatin 75-100 mg/m² IV on day 1 plus 5-FU 750-1000 mg/m²/day continuous IV infusion over 24 h on days 1-4; every 28 d^[38] or
Cisplatin 50 mg/m² IV on day 1 plus leucovorin 200 mg/m² IV on day 1 plus 5-FU 2000 mg/m²/day continuous IV infusion on day 1; every 14 d^{[39, 40]} or
Cisplatin 80 mg/m² IV on day 1 plus capecitabine 1000 mg/m² PO BID daily on days 1-14; every 21 d^{[31, 41]}
Oxaliplatin 85 mg/m² IV on day 1 plus leucovorin 400 mg/m² IV on day 1 plus 5-FU 400 mg/m² IVP on day 1 plus 5-FU 1200 mg/m²/day continuous IV infusion on days 1 and 2; every 14 d^[42] or
Oxaliplatin 85 mg/m² IV on day 1 plus leucovorin 200 mg/m² IV on day 1 plus 5-FU 2600 mg/m²/day continuous IV infusion on day 1; every 14 d^[39] or
Oxaliplatin 130 mg/m² IV on day 1 plus capecitabine 1000 mg/m² PO BID on days 1-14; every 21 d^[43]
Irinotecan 80 mg/m² IV on day 1 plus leucovorin 500 mg/m² IV on day 1 plus 5-FU 2000 mg/m²/day continuous IV infusion on day 1; weekly for 6 wk followed by 1 wk off treatment^[44] or 2 wk off treatment^{[45, 46]}or
Irinotecan 150 mg/m² IV on day 1 plus leucovorin 20 mg/m² IV on day 1 plus 5-FU 1000 mg/m² /day continuous IV infusion on days 1 and 2; every 14 d^[47]

Other regimens^[1]

Paclitaxel 135-200 mg/m² IV on day 1 plus cisplatin 75 mg/m² IV on day 2; every 21 d^[48] or
Paclitaxel 90 mg/m² IV on day 1 plus cisplatin 50 mg/m² IV on day 1; every 14 d^[49] or
Paclitaxel 200 mg/m² IV on day 1 plus carboplatin AUC 5 IV on day 1; every 21 d^[50] or
Docetaxel 70-85 mg/m² IV on day 1 plus cisplatin 70-75 mg/m² IV on day 1; every 21 d^{[51, 52, 53]} or
Docetaxel 35 mg/m² IV on days 1 and 8 plus irinotecan 50 mg/m² IV on days 1 and 8; every 21 d^[54] or
Leucovorin 400 mg/m² IV on day 1 plus 5-FU 400 mg/m² IVP on day 1 plus 5-FU 1200 mg/m²/day continuous IV infusion on days 1 and 2; every 14 d^[40] or
5-FU 800 mg/m²/day continuous IV infusion on days 1-5; every 28 d^[55] or
Capecitabine 1000-1250 mg/m² PO BID daily on days 1-14; every 21 d^[56] or
Docetaxel 75-100 mg/m² IV on day 1; every 21 d^[57] or
Paclitaxel 135-250 mg/m² IV on day 1; every 21 d^[58] or
Paclitaxel 80 mg/m² IV on day 1 weekly; every 28 d^[59]

Stage IV

Trastuzumab 8 mg/m² IV loading dose on day 1 of cycle one, then 6 mg/m² IV; every 21 d with chemotherapy^[31]or
Trastuzumab 6 mg/kg IV loading dose on day 1 of cycle one, then 4 mg/kg IV every 14 d with chemotherapy

Preferred regimens^[1]:

Ramucirumab 8 mg/kg IV on day 1; every 14 d^[60] or
Ramucirumab 8 mg/kg IV on days 1 and 15 plus paclitaxel IV 80 mg/m² on days 1, 8, and 15; every 28 d^[61] or
Docetaxel 75-100 mg/m² IV on day 1; every 21 d^[57] or
Paclitaxel 135-250 mg/m² IV on day 1; every 21 d^[58] or
Paclitaxel 80 mg/m² IV on day 1 weekly; every 28 d^[59] or
Paclitaxel 80 mg/m² IV on days 1, 8, and 15; every 28 d^[62] or
Irinotecan 250-350 mg/m² IV on day 1; every 21 d^[63] or
Irinotecan 150-180 mg/m² IV on day 1; every 14 d^{[64, 65, 62]} or
Irinotecan 125 mg/m² IV on days 1 and 8; every 21 d^{[64, 65]}

For MSI-high or deficient MMR tumors that have progressed despite fluoropyrimidine- and platinum-containing chemotherapy ^[66] :

Pembrolizumab 200mg IV on day 1; every 21 d^{[67, 68]}

Metastatic gastric or gastroesophageal junction adenocarcinoma tumors expressing PD-L1 ≥ 1 (or third line or subsequent therapy)^[69]:

Pembrolizumab 200mg IV on day 1; every 21 d^[70]

Other regimens^[1]:

Irinotecan 65 mg/m² IV on days 1 and 8 plus cisplatin 25-30 mg/m² IV on days 1 and 8; every 21 d^{[42, 71]} or
Irinotecan 250 mg/m² IV on day 1 plus capecitabine 1000 mg/m² PO BID daily on days 1-14; every 21 d^[72] or
Irinotecan 180 mg/m² IV on day 1 plus leucovorin 400 mg/m² IV on day 1 plus 5-FU 400 mg/m² IVP on day 1 plus 5-FU 600-1200 mg/m²/day continuous IV infusion on days 1 and 2; every 14 d^{[73, 74]} or
Docetaxel 35 mg/m² IV on days 1 and 8 plus irinotecan 50 mg/m² IV on days 1 and 8; every 21 d^[54]

Tipiracil/trifluridine:

The FDA approved tipiracil/trifluridine in February 2019 for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy^[75]

Dose based on trifluridine component rounded to nearest 5-mg increment

35 mg/m² PO BID with food on Days 1-5 and Days 8-12 of each 28-day cycle; not to exceed 80 mg/dose until disease progression or unacceptable toxicity

Alternative regimens to consider:

Mitomycin 6 mg/m² IV on day 1 plus irinotecan 125 mg/m² on days 2 and 9; every 28 d^[76] or
Irinotecan 150 mg/m² IV on days 1 and 15 plus mitomycin 8 mg/m² IV on day 1; every 28 d^[77] or
Irinotecan 125 mg/m² IV on day 1 plus mitomycin 5 mg/m² IV on day 1; every 14 d^[78] or
Mitomycin 10 mg/m² IV on days 1 and 22 plus leucovorin 500 mg/m² IV on day 1 plus 5-FU 2600 mg/m²/day continuous IV infusion on day 1; weekly for 6 wk, followed by 2 wk off treatment^[79] or
Regorafenib 160 mg PO daily on days 1 to 21; every 28 d ^[80] or
Nivolumab 3 mg/kg IV on day 1; every 14 d^[81]

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