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Background/aim The aim of the study was to evaluate gemcitabine plus nanoparticle albumin-bound paclitaxel (GnP) and FOLFIRINOX for recurrent pancreatic cancer (rPC) after resection. Patients and methods Forty-four patients with rPC and 211 with de novo metastatic pancreatic cancer (mPC) who received GnP or FOLFIRINOX as first-line chemotherapy were retrospectively analyzed. Results On crude analysis, the median overall survival (OS) was significantly longer in the rPC group than in the mPC group (14.0 vs. 10.6 months, respectively; p=0.02). However, the difference was not significant on adjusted analysis using the Cox proportional hazards model (adjusted p=0.90). Patients receiving FOLFIRINOX (n=10) and GnP (n=34) in the rPC group had comparable OS (medians, 12.2 vs. 14.4 months, respectively; p=0.82) even after adjusting for covariates using the Cox model (adjusted p=0.18). Conclusion The outcomes of patients in the rPC and mPC groups were comparable following chemotherapy. Both FOLFIRINOX and GnP may be reasonable options for treating rPC.

Objectives: Endoscopic-ultrasound-guided hepaticogastrostomy (EUS-HGS) with plastic stent placement is associated with a high incidence of adverse events that may be reduced using an endoscopic retrograde cholangiopancreatography (ERCP) contrast catheter in the track dilation step. In this study, we evaluated the usefulness of track dilation and bile aspiration performed with an ERCP contrast catheter in EUS-HGS with plastic stent placement. Methods: In a multicenter setting, 22 EUS-HGS cases dilated with an ERCP contrast catheter were analyzed retrospectively and compared between a bile aspiration group and no bile aspiration group. Results: Overall, adverse events occurred in three (13.6%) cases of bile leakage, three (13.6%) cases of peritonitis, and one (4.5%) case of bleeding. Comparing patients with and without bile aspiration, 6 of the 11 patients (54.5%) with no bile aspiration had adverse events, whereas only 1 of the 11 patients (9.1%) who had bile aspiration, as much bile as possible, had an adverse event (bleeding). In univariate analysis, the only factor affecting the occurrence of adverse events was bile aspiration whenever possible (odds ratio, 12.0; 95%CI 1.12–128.84). Conclusions: In EUS-HGS with plastic stent placement, track dilation and bile aspiration with an ERCP contrast catheter may be useful in reducing adverse events.

Introduction: Original FOLFIRINOX (oFFX) is more toxic than other regimens for patients with metastatic pancreatic cancer (mPC); therefore, a modified FFX (mFFX) regimen with a reduced dosage has been used in Japanese clinical practice. However, very few studies have compared these two regimens. Methods: This study was conducted as part of a multicenter retrospective study of 318 patients with mPC across 14 centers in Japan (NAPOLEON study). To control for potential bias and confounders, we conducted a propensity score-adjusted analysis of patient characteristics and clinical outcomes. Results: oFFX and mFFX were administered to 48 and 54 patients. More patients with younger age and poorer performance status were included in the oFFX group. The overall survival (OS; median, 11.6 vs. 11.3 months; hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.60–1.40; p = 0.67), progression-free survival (PFS) (median, 6.3 vs. 5.7 months; HR, 0.85; 95% CI, 0.56–1.28; p = 0.44), and overall response rate (29 vs. 26%, p = 0.71) were not significantly different for the oFFX and mFFX groups. Thrombopenia and liver dysfunction were significantly more frequent with oFFX than with mFFX. The median received dose intensity of CPT-11 was higher with oFFX than with mFFX (299 vs. 270 mg/m2/week, p < 0.01). The propensity score-adjusted analysis revealed no statistically significant differences in OS and PFS between the two groups. Conclusion: In our data, there was no significant difference in efficacy between mFFX and oFFX, and mFFX has fewer adverse events.

Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX, FFX) and gemcitabine plus nab-paclitaxel (GnP) are considered standard treatments for patients with metastatic pancreatic cancer. Direct comparisons are not available that establish which is optimal. We conducted a propensity score-adjusted analysis of patients with metastatic pancreatic cancer to identify the therapeutic advantages of these standard therapies. We used clinical data as part of a multicenter retrospective study of patients with unresectable or recurrent pancreatic cancer treated with FFX or GnP (NAPOLEON study). FFX and GnP were initially administered to 102 and 153 patients, respectively. The GnP group comprised more patients of advanced age, worse performance status, lower body mass index, recurrence, and lower albumin concentrations. Median overall survival (OS) and progression-free survival (PFS) were 11.5 months and 5.8 months in the FFX group and 11.1 months and 5.9 months in the GnP group, respectively. Propensity score-adjusted analysis indicated that the administration of FFX or GnP was not independently associated with OS (adjusted hazard ratio [HR] 1.06; 95% confidence interval [CI] 0.76–1.47; P = 0.73). Similarly, the difference in PFS was not significant between groups (adjusted HR 0.93; 95% CI 0.68–1.26; P = 0.62). Gastrointestinal disorders were more common in the FFX group, whereas the frequencies of hematological, nervous system, and skin disorders were higher in the GnP group. The efficacies of FFX and GnP were comparable, although safety profiles differed and should be considered in selecting treatment.

529 Background: Proteinuria is a well-known lenvatinib (LEN)-associated adverse event. The standard management of proteinuria includes measurement of the urinary protein/creatinine ratio (UPCR) in patients with a qualitative result for proteinuria of ≥1+. Although several studies have shown a good correlation of the UPCR with the qualitative result, it remains unclear how the management of proteinuria by measuring the UPCR might affect the clinical outcomes. This study was aimed at revealing the effect of measuring UPCR on the treatment efficacy and safety in unresectable hepatocellular carcinoma (uHCC) patients receiving LEN. Methods: We retrospectively analyzed the data of uHCC patients who received LEN between March 2018 and February 2022 at National Cancer Center Hospital East. Patients in the UPCR group were monitored by measurement of the UPCR when the qualitative result was ≥2+, while those in the non-UPCR group were not. LEN was withdrawn when the UPCR was ≥3.5 in the UPCR group, and the qualitative result for proteinuria was ≥3+ in the non-UPCR group. Results: A total of 89 patients were included in this study, of which 39 had a qualitative result for proteinuria of ≥2+. Of these 39 patients with proteinuria, 22 were classified into the UPCR group and the remaining into the non-UPCR group. Of the 209 qualitative results of ≥2+ in the UPCR group, 10 (4.8%) corresponded to a UPCR of ≥3.5. The relative dose intensity of LEN during the first 8 weeks was significantly higher in the UPCR group (64.4%) than in the non-UPCR group (52.8 %, p = 0.047). The time to treatment failure was 12.6 months (95% CI, 6.3-16.9) in the UPCR group and 5.5 months (95% CI, 2.1-11.0) in the non-UPCR group (p = 0.125). The rate of change in eGFR from the baseline to the end of treatment was not significantly different between two groups. Conclusions: Measurement of UPCR might contribute to avoiding unnecessary interruption of LEN, because the UPCR values in most patients were below 3.5.

705 Background: Nanoliposomal irinotecan plus fluorouracil and folinic acid (nal-IRI/FU/LV; NFF) is the standard regimen after gemcitabine-based therapy for unresectable or recurrent pancreatic cancer (urPC). However, the efficacy and safety of NFF in patients who previously received irinotecan-based chemotherapy remain unclear. Methods: This retrospective study collected data from patients with urPC who received at least one previous chemotherapy before receiving NFF therapy at 21 hospitals in Japan between June 2020 and May 2021 (NAPOLEON-2 study). We analyzed antitumor efficacy, progression-free survival (PFS), and overall survival (OS) after the initiation of NFF and compared adverse events (AEs) between previous irinotecan users and non-users. Results: NFF was administered to 161 patients. The median follow-up period was 7.3 months (95% confidence interval [CI] = 5.6–8.9). All patients received prior gemcitabine-based therapy, and NFF was administered as the second-, third-, and fourth-or-later-line chemotherapy in 104, 41, and 16 patients, respectively. Eighteen patients (11%) previously received irinotecan. Patients’ characteristics did not significantly differ between irinotecan users (n = 18) and non-users (n = 143), excluding age (mean [range], 64 [38–78] vs. 68 [47–85] years; p = 0.01), the lung metastasis rate (44% vs. 14%; p < 0.01), the treatment line (2nd/3rd/4th-or-later, 0%/56%/44% vs. 73%/22%/6%; p < 0.01), and the pretreatment period (15.3 [6.8–45.0] vs. 9.1 [1.4–36.2] months; p < 0.01). The median relative dose intensities of nal-IRI were 87.1% and 81.1% in irinotecan users and non-users, respectively (p = 0.28), and those of FU were 93.5% and 89.2%, respectively (p = 0.54). The objective response rate (6% vs. 5%; p = 0.90), disease control rate (44% vs. 53%; p = 0.49), PFS (2.8 months vs. 3.6 months; hazard ratio [HR] = 1.23; 95% CI = 0.74–2.05; p = 0.42), and OS (9.2 months vs. 8.0 months; HR = 0.88; 95% CI = 0.49–1.57; p = 0.66) did not differ between irinotecan users and non-users, nor did the rates of Grade 3/4 hematological (p = 0.68) and non-hematological (p = 0.13) AEs. Among irinotecan users, the duration of irinotecan-based therapy and the irinotecan-free interval before NFF did not affect the efficacy of NFF. Conclusions: NFF might be effective and safe even in patients with urPC who received irinotecan-based chemotherapy irrespective of its duration or the interval to NFF. Therefore, NFF is a possible treatment option after irinotecan-based chemotherapy. Further studies with a sufficient number of patients and a prospective design are warranted to examine the efficacy of NFF after irinotecan-based chemotherapy.

746 Background: Depth of response (DpR; max% reduction from baseline in sum of target lesion diameters), has been reported to be associated with improved prognosis in several malignancies. However, there have been few reports regarding DpR in patients with locally advanced pancreatic cancer (LAPC). Thus, we investigated the association between DpR and overall survival (OS), and whether there were any differences in treatment efficacy on DpR between modified FOLFIRINOX (mFFX) versus gemcitabine plus nab-paclitaxel (GnP) as 1st-line chemotherapy for LAPC, using the results from JCOG1407 which was a randomized phase II trial comparing these regimens. Methods: Of the 126 patients enrolled in JCOG1407, patients were eligible except for the followings; patients who never had an imaging study or had only non-target lesions. The association between DpR and OS was investigated by dividing DpR into 3 groups at the tertile point (T1, T2 and T3 from largest to smallest), and whether DpR contributes to OS was examined by multivariable analysis. The differences in treatment efficacy between both regimens were investigated byevaluating DpR, time to DpR, and duration of response (DoR). Results: A total of 109 patients were eligible for this study (n = 53/56 in mFFX/GnP). The number of patients in T1, T2, and T3 were 37, 36, and 36, respectively. The median OS of T1, T2, and T3 were 29.3 (95% CI, 21.0-NE), 20.6 (95% CI, 15.8-24.5), and 19.0 months (95% CI, 12.7-22.4), respectively ( P= 0.0237). Multivariable analysis identified DpR as an independent prognostic factor for OS (HR 1.883, 95% CI 1.030-3.442, P= 0.040 for T2 vs. T1, and HR 2.523, 95% CI 1.342-4.744, P= 0.004 for T3 vs. T1). The median DpR in GnP was better than that in mFFX (28.9 vs. 22.7%; P= 0.041). The median DoR in mFFX tended to be longer compared to that in GnP (8.2 vs. 5.3 months; P= 0.132). No differences in mean time to DpR were observed between the two regimens. Conclusions: In LAPC patients receiving 1st-line chemotherapy, larger DpR contributed to OS. Although OS and PFS between mFFX and GnP were similar, the treatment efficacy on DpR and DoR might be different between the two regimens. Clinical trial information: UMIN000023143 .

Objectives FOLFIRINOX (FFX, a combination of oxaliplatin, irinotecan, fluorouracil, and leucovorin) and gemcitabine plus nab-paclitaxel (GnP) have been used as standard, first-line treatments for advanced pancreatic cancer. However, no study has compared the efficacy of the 2 regimens. This study retrospectively compared the efficacy and safety of the 2 regimens in patients with locally advanced pancreatic cancer. Methods We reviewed the records of patients with locally advanced pancreatic cancer who started FFX or GnP as first-line chemotherapy as part of a multicenter retrospective study in patients with unresectable pancreatic cancer treated with FFX or GnP (NAPOLEON study). Results Sixteen of the 63 patients were treated with FFX, and the other 47 patients were treated with GnP between December 2013 and March 2017. There were no significant differences in median overall survival rate between the GnP (15.5 months) and FFX (14.3 months, P = 0.60) groups or median progression-free survival rate between the GnP (8.8 months) and FFX (8.1 months, P = 0.51) groups. Both treatments were generally well tolerated, although anorexia was more severe in the FFX group than in the GnP group. Conclusions The effects of FFX and GnP were similar but resulted in different toxicities, which could guide agent choice.

Background : In patients with distal malignant biliary obstruction, it is a challenge to manage acute cholecystitis secondary to cystic duct obstruction associated with tumor progression or stent compression. Percutaneous transhepatic gallbladder drainage (PTGBD) has been used as the treatment option of choice, because of its ease of performance and safety, but because of the use of an external drainage tube, some patients experience a decreased quality of life. We report the technical success and clinical success of conversion from PTGBD to endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) for the treatment of acute cholecystitis in patients with unresectable malignant biliary obstruction. Methods : We included the patients with cholecystitis secondary to unresectable malignant biliary obstruction who underwent conversion from PT-GBD to EUS-GBD in the study. After PTGBD for the treatment of acute cholecystitis, we performed EUS-GBD and a plastic stent or a self-expandable metal stent (SEMS) was placed for fistulostomy. Results : Fourteen patients (median age, 69 years; 9 males and 5 females) underwent conversion to EUS-GBD after clinical improvement of cholecystitis by PTGBD. The technical success rate of the conversion from PTGBD to EUS-GBD was 100% (14/14). EUS-GBD was performed in a median of 9.5 days (range, 3-51 days) after PTGBD procedure, using mainly a plastic stent (13 patients) and a covered SEMS in one patient. The early (within 24 hours) adverse events rate was 14.3% (2/14), and the late (after 24 hours) adverse events rate was 7.1% (1/14). The rate of recurrence of cholecystitis was 28.6% (4/14). These patients underwent endoscopic re-intervention and there were no cases of further recurrence of cholecystitis. Conclusion : Conversion of PTGBD to EUS-GBD demonstrated a feasible and safe technique for acute cholecystitis in non-surgical candidates with malignant biliary obstruction.

The aim of the study was to evaluate gemcitabine plus nanoparticle albumin-bound paclitaxel (GnP) and FOLFIRINOX for recurrent pancreatic cancer (rPC) after resection.Forty-four patients with rPC and 211 with de novo metastatic pancreatic cancer (mPC) who received GnP or FOLFIRINOX as first-line chemotherapy were retrospectively analyzed.On crude analysis, the median overall survival (OS) was significantly longer in the rPC group than in the mPC group (14.0 vs. 10.6 months, respectively; p=0.02). However, the difference was not significant on adjusted analysis using the Cox proportional hazards model (adjusted p=0.90). Patients receiving FOLFIRINOX (n=10) and GnP (n=34) in the rPC group had comparable OS (medians, 12.2 vs. 14.4 months, respectively; p=0.82) even after adjusting for covariates using the Cox model (adjusted p=0.18).The outcomes of patients in the rPC and mPC groups were comparable following chemotherapy. Both FOLFIRINOX and GnP may be reasonable options for treating rPC.

Background No reliable nomogram has been developed until date for predicting the survival in patients with unresectable pancreatic cancer undergoing treatment with gemcitabine plus nab-paclitaxel (GnP) or FOLFIRINOX (FFX).Methods This analysis was conducted using clinical data of patients with unresectable pancreatic cancer undergoing GnP or FFX treatment obtained from a multicenter study (NAPOLEON study). A Cox proportional hazards model was used to identify the independent prognostic factors. A nomogram to predict 6-, 12-, and 18-month survival probabilities was generated, validated by using the concordance index (C-index), and calibrated by the bootstrapping method. And then, we attempted risk stratification for survival by classifying the patients according to the sum of the scores on the nomogram (total nomogram points; TNP).Results A total of 318 patients were enrolled. A prognostic nomogram was generated using data on the Eastern Cooperative Oncology Group performance status, liver metastasis, serum LDH, serum CRP, and serum CA19-9. The C-indexes of the nomogram were 0.77, 0.72 and 0.70 for 6-, 12-, and 18-month survival, respectively. The calibration plot showed optimal agreement at all points. Risk stratification based on tertiles of the TNP yielded clear separations of the survival curves. The median survival times in the low-, moderate-, and high-risk groups were 15.8, 12.8 and 7.8 months (PConclusions: Our nomogram is a convenient and inexpensive tool to accurately predict survival in patients with unresectable pancreatic cancer undergoing treatment with GnP or FFX, and will help clinicians in selecting appropriate therapeutic strategies for individualized management.

Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been utilized as an alternative endoscopic technique for patients with acute cholecystitis. In addition to EUS-guided hepaticogastrostomy and EUS-guided cystogastrostomy, EUS-GBD has been reported as being useful for biliary drainage in cases with distal malignant biliary obstruction instead of conventional endoscopic retrograde cholangiopancreatography. We present a case of successful EUS-GBD for malignant obstruction of an aberrant hepatic duct draining directly into the cystic duct.

Precision medicine in cancer treatment refers to targeted therapy based on the evaluation of biomarkers. Although precision medicine for pancreatic cancer (PC) remains challenging, novel biomarker-based therapies, such as pembrolizumab, olaparib, and entrectinib, have been emerging. Most commonly, endoscopic ultrasound-guided tissue acquisition (EUS-TA) had been used for the diagnosis of PC until now. However, advances in EUS-TA devices and biomarker testing, especially next-generation sequencing, have opened up the possibility of sequencing of various genes even in limited amounts of tissue samples obtained by EUS-TA, and identifying potential genetic alterations as therapeutic targets. Precision medicine benefits only a small population of patients with PC, but biomarker-based therapy has shown promising results in patients who once had no treatment options. Now, the role of EUS-TA has extended beyond diagnosis into decision-making regarding the treatment of PC. In this review, we mainly discuss tissue sampling by EUS-TA for biomarker testing and the current status of precision medicine for PC.

BACKGROUND It is important to avoid relapse in autoimmune hepatitis (AIH) because repeated multiple relapses have been associated with a worse prognosis. However, risk factors for relapse before initiation of treatment are not fully understood. The aim of this study was to find predictive markers for relapse of type 1 AIH. MATERIAL AND METHODS We reviewed the records of 53 patients diagnosed with type 1 AIH based on the revised scoring system proposed by the International Autoimmune Hepatitis Group (IAIHG) between 2009 and 2014 at 4 hospitals belonging to the Saga Study Group of Liver Diseases (SASLD). We analyzed the differences in background characteristics between patients with or without relapse. RESULTS All patients achieved remission after treatment, and 9 (17%) subsequently relapsed. The relapsed patients were significantly younger and had a higher positive rate of anti-smooth muscle antibody (ASMA) than the non-relapsed patients (100% vs. 25%, P=0.0012). Moreover, relapse rate increased with titer of ASMA, while titer of antinuclear antibody was not associated with relapse rate. CONCLUSIONS ASMA is a useful predictive marker for relapse of type 1 AIH during or after withdrawal of medical therapy. More careful attention should be paid to immunosuppressive therapy in patients with high titers of ASMA.

661 Background: Gemcitabine plus nab-paclitaxel (GnP) and FOLFIRINOX (FFX) have been established as standard first-line combination chemotherapy (CTx) for patients with metastatic pancreatic cancer (MPC). However, the efficacy of second-line CTx and the significance of combination CTx in clinical practice are unclear. We therefore investigated the efficacy of second-line CTx in patients with MPC. Methods: Data were collected from CTx-naive MPC patients treated with first-line combination CTx at 14 hospitals in the Kyushu area of Japan from December 2013 to June 2018. The median overall survival (mOS) from second-line treatment was compared between patients who received second-line CTx (CT group) and those who received best supportive care (BSC group). Furthermore, in the CT group, the mOS was compared between the patients who received combination CTx and those who received mono-CTx. To control potential bias in the selection of second-line treatment, we also conducted a propensity score-adjusted analysis. Results: A total of 255 patients received GnP or FFX as first-line CTx. Of these, there were 156 (61%) in the CT group and 77 (30%) in the BSC group. The number of patients who received FFX/GnP as first-line CTx was 79 (51%)/77 (49%) in the CT group and 15 (20%)/62 (80%) in the BSC group, respectively (P < 0.01). The mOS in the CT group was significantly longer than that in the BSC group (5.2 vs. 2.7 months; hazard ratio [HR] 0.42; 95% confidence interval [CI] 0.31-0.57; p < 0.01 and 5.2 vs. 2.6 months; adjusted HR 0.39; 95% CI 0.28-0.55; p < 0.01). In the CT group, 89 (57%) patients received combination CTx, and 67 (43%) received mono-CTx. There was no significant difference in the mOS between the combination CTx and mono-CTx patients (5.5 vs. 4.4 months; HR 0.88; 95% CI 0.62-1.26; p = 0.88 and 5.6 vs. 4.4 months; adjusted HR 0.85; 95% CI 0.56-1.30; p = 0.47). Conclusions: Among patients with MPC receiving second-line treatment, the CT group had a significantly longer mOS than the BSC group, but combination CTx conferred no improvement in the survival duration compared with mono-CTx.

Background GEM plus nab-PTX (GnP) and FOLFIRINOX (FFX) have been shown to improve overall survival for advanced pancreatic cancer patients. However, clinical utility of C-reactive protein/albumin ratio (CAR) as prognostic factor for the patients treated with GnP or FFX remains unclear. We conducted the exploratory analysis to elucidate prognostic impact of CAR using a multicenter retrospective study (the NAPOLEON study) cohort which examined the efficacy and safety of GnP and FFX in clinical practice. Methods Between December 2013 to March 2017, 255 patients with unresectable advanced or recurrent pancreatic cancer who received GnP or FFX as 1st-line chemotherapy at 14 centers participating in the NAPOLEON study were examined. Patient characteristics at the start of 1st and 2nd line chemotherapy including age, gender, ECOG performance status, primary tumor site, disease status, metastatic site, underwent biliary drainage or not, treatment regimen at 1st line chemotherapy, LDH and CAR were analyzed to investigate correlation with prognosis by Cox regression model. The cut-off value of CAR adopted 0.54 based on a previous study. Patients were divided into groups according to CAR level less than 0.54 (CAR-low) and 0.54 or greater (CAR-high). Results Cox regression analysis of OS identified underwent biliary drainage (HR: 1.76, 95%CI: 1.19–2.61), CAR-high (HR: 1.52, 95%CI: 1.05–2.21), and higher LDH level (HR: 2.10, 95%CI: 1.36–3.22) as significant factors at the start of 1st-line chemotherapy. Similarly, Cox regression analysis of OS identified a poor PS (HR: 1.62, 95%CI: 1.07–2.47), a high level of CA19-9 (HR: 2.14, 95%CI: 1.07–4.29) and CAR-high (HR: 2.15, 95%CI: 1.32–3.49) as significant factors at the start of 2nd-line chemotherapy. Eighty-six of 140 patients (82.7%) with CAR-high at the start of 1st-line chemotherapy still remained CAR-high at the start of 2nd-line chemotherapy. Conclusions CAR may be useful prognostic factor at the start of both 1st and 2nd-line treatment. Almost all the patients with CAR-high before 1st line treatment still remained CAR-high after 1st line treatment. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background Gemcitabine plus nab-paclitaxel (GnP) and FOLFIRINOX (FFX) are both considered as standard chemotherapy for patients with metastatic pancreatic cancer (mPC). However, there are no prospective clinical trials that directly compare these two therapies. We investigate and compare them to support the treatment selection for mPC. Methods: We retrospectively analyzed the patients with mPC who had received GnP or FFX as first-line chemotherapy at 14 institutions in Kyushu. In this study, patient characteristics and clinical outcomes; overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and adverse events (AEs) were compared. Results: A total of 211 pts were included; GnP 119 pts (73 males and 46 females) and FFX 92 pts (55 males and 37 females). The median age of the FFX group was younger than that of GnP (GnP 68 vs. FFX 61 years). There was neither significant difference in the OS (median: 10.2 vs. 11.1 months, HR 0.98, 95%CI 0.72-1.34, p = 0.91) nor the PFS (median: 5.5 vs. 5.7 months, HR 1.05, 95%CI 0.79-1.40, p = 0.75) between the GnP and FFX group, respectively. Moreover, neither significant difference in the ORR (29% vs. 27%, p = 0.72) nor the DCR (81% vs. 79%, p = 0.25) was seen. There were no significant differences in grade 3/4 neutropenia (55% vs. 58%) and febrile neutropenia (10% vs. 13%). Grade 3/4 peripheral sensory neuropathy (12% vs. 3%) and fatigue (4% vs. 0%) were more frequent with GnP. All grades of rash and alopecia were more frequent with GnP. Otherwise, grade 3/4 anorexia (6% vs. 20%), diarrhea (0% vs. 11%) and nausea (3% vs. 11%) were more with FFX. 64% of the patients with FFX received GnP as second-line, but the rate of patients with FFX followed by GnP was only 10%. Conclusions: There was no significant difference in the effectiveness between GnP and FFX statistically. We need to select the appropriate treatment for each patient, considering that the toxicity profiles differ.