Tetsuji Terazawa

Efficacy of Prophylactic G-CSF in Patients Receiving FOLFIRINOX: A Preliminary Retrospective Study.

OBJECTIVE Recent guidelines have adopted an incidence of febrile neutropenia (FN) threshold of 20% for the use of prophylactic granulocyte colony-stimulating factor (G-CSF). In a Japanese phase II study of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) for Japanese patients with advanced pancreatic cancer, the incidence of FN and severe neutropenia were 24.7% and 77.8%, respectively, without G-CSF prophylaxis. The aim of this retrospective study was to investigate the incidence of FN or severe neutropenia induced by full-dose FOLFIRINOX administration with G-CSF prophylaxis during the first cycle of treatment. METHODS Patients with advanced pancreatic cancer who received FOLFIRINOX with G-CSF prophylaxis during the first cycle of treatment from January 2014 to August 2014 were investigated and the frequency of adverse events during the first cycle was measured. RESULTS Among seven patients who received FOLFIRINOX, six patients met the eligibility criteria. The patient characteristics were as follows: median age (range), 57 (50-66); men/women, 3/3; performance status 0/1, 2/4. Grade 3/4 hematological adverse events were as follows: leukopenia in 33% of the patients, neutropenia in 33% of the patients, thrombocytopenia in 33% of the patients and FN in 17% of the patients. One patient was heterozygous for the UGT1A1*6 and UGT1A1*28 polymorphisms and experienced FN. Grade3/4 non-hematological adverse events were as follows: anorexia in 33% of the cases and nausea in 50% of the cases. CONCLUSION Although the present study was retrospective and small, the simultaneous administration of G-CSF might be effective for the prevention of severe neutropenia and FN in patients treated with FOLFIRINOX.

Phase II study of cetuximab with irinotecan for KRAS wild-type colorectal cancer in Japanese patients.

Cetuximab improves the prognosis for wild‐type KRAS metastatic colorectal cancer (MCRC). We evaluated the safety and efficacy of cetuximab in combination with irinotecan in Japanese patients with wild‐type KRAS MCRC refractory to irinotecan, oxaliplatin and fluoropyrimidines.

Efficacy and feasibility of neoadjuvant chemotherapy and chemoradiotherapy for elderly patients with stage IB/II/III (excluding T4) esophageal cancer: Retrospective study.

135 Background: Neoadjuvant chemotherapy (NAC) of 5-fluorouracil plus cisplatin infusion (FP) is standard therapy for stage IB/II/III (excluding T4) esophageal cancer from results of JCOG9907 and definitive chemoradiotherapy (dCRT) of FP is one of the curative options for resectable esophageal cancer with organ preservation results of JCOG9906 in Japan. However, the efficacy and feasibility of NAC FP and CRT for elderly patients (pts) are unclear. Methods: We examined stage IB/II/III (excluding T4) esophageal cancer pts aged 70 or over, who received NAC FP or dCRT at our institution between April 2008 and August 2015, retrospectively. Results: 16 pts received NAC FP at least 1 course, while 5 pts received dCRT because of intolerability for surgery, reject of surgery, and patients wish. Median age was 73/75 (NAC FP/dCRT) and pts in NAC FP had more advanced stage cancer compared with pts in dCRT (p = 0.02). With respect to the toxicity, bone marrow depression developed in dCRT with more high frequency comp...

1492PTHE IMPACT OF ADDING APREPITANT FOR THE PATIENTS RECEIVING MODERATE RISK OF EMETOGENIC CHEMOTHERAPY, A PROSPECTIVE, RANDOMIZED, CROSS-OVER TRIAL.

ABSTRACT Aim: Aprepitant, a neurokinin 1 antagonist, showed efficacy for chemotherapy-induced nausea and vomit(CINV). Antiemetic guidelines recommend aprepitant for high emetogenic chemotherapy(HEC). This prospective, randomized, cross-over trial aimed to evaluate the efficacy of aprepitant for patients(pts) receiving moderate emetogenic chemotherapy(MEC). Methods: Gastrointestinal cancer pts receiving MEC were randomly assinged to GroupA and B. We administered as follows; in GroupA; on first course, pts received palonosetron (0.75mg iv on day 1) and dexamethasone (9.9mg on day 1, and 8mg p.o. on days 2-3) (control premedication) and on second course, pts received oral aprepitant (125mg on day 1 and 80mg on days 2-3) with control premedication (dexamethasone; 4.95mg iv and 4mg p.o.). In GroupB, pts received aprepitant with control premedication on the first course and they received control premedication on second course. The primary endpoint was rate of CR (complete response; neither emesis nor rescue therapy) and degree of nausea. Results: From January 2011 to March 2013, 100 pts were enrolled, and 83 pts were analyzed(female/male, 35/48; median age, 65 years; colorectal/gastric, 64/19; irinotecan/oxaliplatin 53/30). The CR rates of aprepitant/control were 73.5%/60.2%(p = 0.064). The degree of nausea was(more than intermediate) was 4.9%/19.0%(p = 0.02). Conclusions: Adding aprepitant significantly reduced moderate and severe emesis compared with standard premedication. Although the rate of CR was not statistically significant, aprepitant reduced the degree of nausea. Adding aprepitant is promising for gastrointestinal cancer pts receivig MEC. Disclosure: All authors have declared no conflicts of interest.

Transarterial infusion chemotherapy with cisplatin plus S-1 for treating hepatocellular carcinoma: Results of a phase I trial.

357 Background: In Japan, transarterial infusion chemotherapy (TAI) with cisplatin (CDDP) is used for advanced hepatocellular carcinoma (HCC) patients (pts), and the response rate (RR) was 33.8% in previous phase (P) II study. S-1, oral systematic chemotherapy, is also promised for advanced HCC pts, and achieved 23.1% RR in previous P-II study. The clinical feasibility and efficacy of CDDP for TAI plus S-1 in pts with advanced HCC has not yet been investigated. Thus, we performed this trial to determine the recommended dose (RD). METHODS Although 13 Child-Pugh class A or B pts with advanced HCC entered themselves for this P-I trial, 1 pts of them was excluded from this trial due to the breach of criteria. The pts received TAI with CDDP (infusion on day 1 of the courses) plus S-1 (daily oral administration on days 1-21 of the courses), every 5 weeks until disease progression. The dose-escalation scheme is provided in the table below. RESULTS Three dose levels were used for the 12 pts. Dose-limiting toxicity was not observed in 3 pts at level 1, 3 pts at level 2, and 7 pts at level 3; therefore, the RDs for CDDP and S-1 were considered to be 65 mg/m2 and 80-120 mg/day, respectively (level 3). Grade 3 adverse events were reported for 10 pts and were considered to be related to the study drugs for 6 pts: 2 pts, increased alanine aminotransferase level; 2 pts, increased aspartate aminotransferase level; 1 pt, anemia; and 1 pt, decreased platelet count. The total number of treatment courses was 25, with a mean of 1.5 courses per pt (range, 1-6 courses). The median progression-free survivaltime was 73 days. The disease control rate was 58% (7/12) ; 2 pts (16%) achieved partial response and 5 (42%) had stable disease. CONCLUSIONS TAI with CDDP plus S-1 can be used safely with promising tumor control for treating advanced HCC. The RD to be used for a P-II study of this regimen was determined to be level 3. [Table: see text].