Phase II study: Induction chemotherapy & transoral surgery as definitive treatment (Tx) for locally advanced oropharyngeal squamous cell carcinoma (OPSCC): An update and retrospective review of non-study patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18549-e18549
Author(s):  
Robert S. Siegel ◽  
Punam Thakkar ◽  
Nader Sadeghi ◽  
Joseph Goodman ◽  
Arjun Joshi ◽  
...  
Keyword(s):  
Neck Dissection ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Retrospective Review ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Stage Iii ◽  
Definitive Treatment ◽  
Adjuvant Radiation

e18549 Background: The standard of care for OPSCC includes chemoradiation (CRT) or surgery with adjuvant radiation (RT). However, RT is associated with significant life long morbidity. We assessed the efficacy of a two-drug induction regimen, followed by transoral robotic assisted surgery (TORS) & neck dissection for locally advanced OPSCC. Methods: This is an IRB approved single-arm phase II study for untreated stage III or IVA (AJCC 7th edition) OPSCC patients (pts) with an ECOG < 2 and GFR > 50 cc. Induction cisplatin 75 mg/m2 and docetaxel 75 mg/m2 was administered every 21 days for 3 cycles. Patients then underwent TORS and neck dissection(s). At post-op visits, flexible laryngoscopy, blood tests, and imaging with PET/CT and/or MRI were done. Short and long term toxicity, progression-free survival, overall survival, and quality of life (QOL) were evaluated in all pts. Results: Twenty oropharyngeal pts were treated, 19 were male, 17 were Caucasian, and 19 were HPV+. Median age at dx was 57. Three pts were stage III, and 17 were stage IVA. Pathologic CR at the primary site occurred in 15 pts and CR among LN neck dissections occurred in 13 pts. Four pts were given dose-reduced chemo and 1 pt was changed to carboplatin per protocol because of renal dysfunction. Pre vs post tx QOL scores did not change. At a mean follow-up of 40.7 months (range 13 to 55), 18 pts are alive and NED. Three pts recurred a mean of 2.2 mos after surgery, and were treated with salvage CRT. Two pts died of metastatic disease, the third is alive and well. All 3 pts had positive LN (9 LN, 3 LN and 1 LN) at surgery. A fourth pt had 12 pos LN and received radiation. He has not recurred. A retrospective review of an additional 20 twenty pts treated in the same way, were also reviewed for efficacy. Mean age was 61.5. Two pts died of metastatic disease. Twenty pts have been followed for > 13 mos (17 are alive and well, 2 died, and 1 LFU), and their mean follow-up is 43.5 mos. Conclusions: Cisplatin + docetaxel followed by TORS & neck dissection(s) appears to be an effective model for the definitive treatment for OPSCC, while avoiding the adverse effects of RT. Clinical trial information: NCT02760667.

Phase II study: Induction chemotherapy and transoral surgery as definitive treatment (Tx) for locally advanced oropharyngeal squamous cell carcinoma (OPSCC)—An update and retrospective review of non-study patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6072-6072 ◽  
Author(s):  
Robert S. Siegel ◽  
Arjun Joshi ◽  
Reza Taheri ◽  
Nader Sadeghi ◽  
Punam Thakkar ◽  
...  
Keyword(s):  
Overall Survival ◽  
Neck Dissection ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Retrospective Review ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Stage Iii ◽  
Definitive Treatment ◽  
Adjuvant Radiation

6072 Background: The standard of care for OPSCC includes chemoradiation (CRT) or surgery with adjuvant radiation (RT). However, RT is associated with significant life long morbidity. We assessed the efficacy of a two-drug induction regimen, followed by transoral robotic assisted surgery (TORS) & neck dissection for locally advanced OPSCC. Methods: This is an IRB approved single-arm phase II study for untreated stage III or IVA (AJCC 7th edition) OPSCC patients (pts) with an ECOG < 2 and GFR > 50 cc. Induction cisplatin 75 mg/m2 and docetaxel 75 mg/m2 was administered every 21 days for 3 cycles. Patients then underwent TORS and neck dissection(s). At post-op visits, flexible laryngoscopy, blood tests, and imaging with PET/CT and/or MRI were done. Short and long term toxicity, progression-free survival, overall survival, and quality of life (QOL) were evaluated in all pts. Results: Twenty oropharyngeal pts were treated, 19 were male, 17 were Caucasian, and 19 were HPV+. Median age at dx was 57. Three pts were stage III, and 17 were stage IVA. Pathologic CR at the primary site occurred in 15 pts and CR among LN neck dissections occurred in 13 pts. Four pts were given dose-reduced chemo and 1 pt was changed to carboplatin per protocol because of renal dysfunction. Pre vs post tx QOL scores did not change. At a mean follow-up of 33 months (range 19.6 to 44.1), 18 pts are alive and NED. Three pts recurred a mean of 2.2 mos after surgery, and were treated with salvage CRT. Two pts died of metastatic disease, the third is alive and well. All 3 pts had positive LN (9 LN, 3 LN and 1 LN) at surgery. A fourth pt had 12 pos LN and received radiation. He has not recurred. A retrospective review of an additional 20 twenty pts treated in the same way, were also reviewed for efficacy. Mean age was 61.5. Two pts died of metastatic disease. Fourteen pts have been followed for > 7 mos, and their mean overall survival is 44 mos. Conclusions: Cisplatin + docetaxel followed by TORS & neck dissection(s) appears to be an effective model for the definitive treatment for OPSCC, while avoiding the adverse effects of RT.

Phase II study: Induction chemotherapy & transoral surgery as definitive tx for locally advanced oropharyngeal squamous cell carcinoma (OPSCC)—A novel approach.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6078-6078 ◽  
Author(s):  
Robert S. Siegel ◽  
Hind Rafei ◽  
Arjun Joshi ◽  
Khaled El-Shami ◽  
Reza Taheri ◽  
...  
Keyword(s):  
Neck Dissection ◽  
Induction Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Stage Iii ◽  
Transoral Surgery ◽  
Adjuvant Radiation

6078 Background: The standard of care for OPSCC includes chemoradiation (CRT) or surgery with adjuvant radiation (RT). However, RT is associated with significant life long morbidity. We assessed the efficacy of a two-drug induction regimen, followed by transoral robotic assisted surgery (TORS) & neck dissection for locally advanced OPSCC. Methods: This is an IRB approved single-arm phase II study for untreated stage III or IVA OPSCC patients (pts) with an ECOG < 2 and GFR > 50 cc. Induction chemotherapy consisted of cisplatin 75 mg/m2 and taxotere 75 mg/m2 every 21 days for 3 cycles. Tumor shrinkage was examined after each cycle. If the primary tumor was > 80% smaller, pts underwent TORS and neck dissection(s). At post-op visits, flexible laryngoscopy, blood work, and imaging with PET/CT and/or MRI were done. Short and long term toxicity, progression-free survival (PFS) and overall survival (OS), and quality of life (QOL) were evaluated. Results: Nineteenpts were treated and 14 are available for analysis. Thirteen were male, 12 were Caucasian, 2 were African-American, and 13 were HPV+. Median age at diagnosis was 57. Tumors involved the tonsil (11 pts) and base of tongue (3 pts). Three pts were stage III, and 11 were stage IVA. Tumor size was reduced on average by 58%, 84% and 92% after the 1st, 2nd and 3rd induction cycles respectively. Pathologic complete remission of primary disease occurred in 11 pts and in 7 pts with cervical lymph node disease. Four pts were given dose-reduced chemo and one pt was changed to carboplatin per protocol because of renal dysfunction. In addition, adverse events included three patients with grade I fatigue, neuropathy or nausea. Pre vs post tx QOL scores were not significantly different. At a mean follow-up (f/u) of 13 months (range 2.5 to 19.7), 13 pts are alive and well. Three pts recurred, and were treated with salvage CRT. One pt died of metastatic disease. Conclusions: Cisplatin + Taxotere is an effective induction tx for OPSCC, Induction tx followed by transoral & neck resections without RT is a promising tx model for OPSCC. It appears effective while avoiding adverse effects of RT. Longer f/u is required to assess its true efficacy. Clinical trial information: NCT02760667.

Long term follow up data of a phase II study of concurrent radiotherapy (RT) and gemcitabine (Gem) for patients with stage III or IV squamous cell carcinoma of the head and neck (SCCHN)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5574-5574
Author(s):  
P. M. Specenier ◽  
D. Van Den Weyngaert ◽  
C. Van Laer ◽  
J. Van Den Brande ◽  
M. Huizing ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Radical Neck Dissection ◽  
Locally Advanced ◽  
Tube Feeding ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Free Survival

5574 Background: RT with concurrent chemotherapy is superior to RT alone as treatment for locally advanced SCCHN. Gem is a potent radiosensitizer in vitro and in vivo and in addition has a good activity in SCCHN. Exploitation of these properties was the rationale for a single institution phase II study which evaluates the efficacy and toxicities of standard RT + weekly low dose Gem. Methods: Eligible were patients with primary inoperable or locally advanced stage III and IV SCCHN. Treatment: Planned RT was 70 Gy over 7 weeks with weekly Gem 100 mg/m2 within 2 hours prior to RT (Eisbrüch et al., ASCO, 1997, 1998). Presented endpoints are response rate (according to WHO), acute and late toxicity (according to NCICTC), disease free survival (DFS), local relapse free survival (LRFS) and overall survival (OS). Results: 26 patients (21 male, 5 female; performance status 0–2; no prior treatment) entered the study between November 1998 and September 2003. Median age was 56 years (range 48–78). Tumor sites were oropharynx (6), hypopharynx (17), glottis (1), paranasal sinus (1), unknown (1). Clinical stage was III (2) or IV (24). 7 Patients had T4N2 disease and 2 had T4N3 disease. Patients received a median of 7 Gem cycles (range 2–8) and a median of 70 Gy (66–84.75). 7 patients underwent radical neck dissection. Grade 3–4 acute toxicities included mucositis (22/26), dermatitis (18/26), pharyngitis and/or oesophagitis (21/26), pain (7/25), xerostomia (1/24), neutropenia (1/26) and anemia (1/26). 21/26 patients needed tube feeding and 21/26 needed to be hospitalized. After recovery from acute toxicity 6/23 could feed normally, 5/23 needed soft food, 5/23 were able to swallow liquid food and 2/23 required permanent tube feeding. Response was evaluable in 22 patients (11 CR, 11 PR). Intial relapse was at distant sites in 9/26 and local in 8/26. Median follow up of the patients still alive is 46 months. Median OS is 576 days, median DFS is 401 days, median LRFS is not reached. 7/26 remain free of disease more than 3 years after end of treatment. Conclusions: RT + Gem (100 mg/m2/week) is feasible but toxic. The combination is highly active in SCCHN and provides a good long term local control. [Table: see text]

Treatment of advanced non-small cell lung cancer (NSCLC) with a biweekly schedule of irinotecan (I), paclitaxel, and cisplatinum (P): A phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e19076-e19076
Author(s):  
M. Gonzalez ◽  
J. Rebollo ◽  
R. Rami ◽  
J. Belda ◽  
J. Farré ◽  
...  
Keyword(s):  
Phase Ii ◽  
Advanced Nsclc ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Metastatic Tumor ◽  
Complete Response ◽  
Time To Progression ◽  
Good Tolerance ◽  
Confirmatory Phase

e19076 Background: Irinotecan, paclitaxel (taxol, T), and cisplatinum are among the most active agents in the treatment of NSCLC, given alone as single agents or in combination. Based in previous data (Proc ASCO 2003 # 2816), we performed a confirmatory phase II study of the activity of a bi-weekly combination of I (120 mg/m2), T(60 mg/m2) and P (40 mg/m2) in advanced NSCLC. Methods: Forty-three patients (pts) (37 male, 6 female) with histologically proven IIIA-IV NSCLC were treated at our institution. Median age was 61 years (33–79). All pts were ECOG 0–2. 14 pts had locally advanced disease (8 IIIA, 6 IIIB) and 29 metastatic disease. Previous treatments included surgery (5 pts), radiotherapy (4 pts), chemotherapy (5 pts), surgery + radiotherapy (3 pts) and surgery + chemotherapy (2 pt). In three cases, treatment was administered as adjuvant after resection of a primary (2 cases) or a metastatic tumor (1 case). Results: A total of 299 courses were administered (median 6, range 2–14). Toxic episodes grade III-IV were neutropenic fever (10/299; 3.3%), anemia (1/299; 0.3%), asthenia (3/299; 1%), diarrhea (5/299; 17%), hemorrhagic colitis (1/299; 0.3%), mucositis (2/299, 0.6%), vomiting (4/299; 1.3%) and peripheral neuropathy (1/299; 0.3%). With a median follow-up of 72 months (9–97), 2 pts (4.6%) presented pathological complete response, 26 (60%) partial response, 11 (25%) stable disease and 1 pt progressed. Four partial responders were rendered free of disease after rescue surgery. Median time to progression was 6 months. Median survival was 10 months. The actuarial 2 and 5-year overall survival are 26% and 13% respectively. Conclusions: I, T and P at the referred doses can be safely administered in a bi-weekly basis, with a good tolerance and response rate in advanced NSCLC pts. No significant financial relationships to disclose.

scholarly journals Cetuximab Plus Cisplatin, Irinotecan, and Thoracic Radiotherapy as Definitive Treatment for Locally Advanced, Unresectable Esophageal Cancer: A Phase-II Study of The SWOG (S0414)

2012 ◽  
Vol 7 (5) ◽  
pp. 906-912 ◽  
Author(s):  
Michael B. Tomblyn ◽  
Bryan H. Goldman ◽  
Charles R. Thomas ◽  
Jacqueline K. Benedetti ◽  
Heinz-Josef Lenz ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Definitive Treatment ◽  
Thoracic Radiotherapy

Phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small cell lung cancer: CALGB 30407

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7505-7505
Author(s):  
R. Govindan ◽  
J. Bogart ◽  
X. Wang ◽  
L. Hodgson ◽  
R. Kratzke ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Phase Ii ◽  
Chemotherapy Regimen ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Small Cell ◽  
Small Cell Lung ◽  
Thoracic Radiation

7505 Background: Cisplatin, etoposide and concurrent thoracic radiation has remained the standard treatment for locally advanced unresectable non small cell lung cancer (NSCLC) over the past two decades. The Cancer and Leukemia Group B (CALGB) conducted a phase II study using a novel chemotherapy regimen administered in systemically active doses with thoracic radiation (CALGB 30407). We previously reported the preliminary safety results (ASCO 2008, abstract 7518). Methods: Eligible patients with previously untreated stage III NSCLC received thoracic radiation (70 Gy) along with carboplatin (AUC 5) and pemetrexed 500 mg/m2 on day 1 administered intravenously every 21 days for 4 cycles (arm A) or the same chemotherapy regimen with weekly cetuximab for 6 weeks concurrent with radiation (arm B). All patients received four additional cycles of pemetrexed (500 mg/m2 every 21 days) as consolidation therapy. The primary endpoint was the percentage of patients who lived longer than 18 months after starting initial treatment. We planned to study the regimen (s) further if the 18 month survival rates equaled or exceeded 55%. Results: Characteristics of the 99 eligible pts (48 in arm A and 51 arm B) enrolled from 09/05 to 1/08: male 62%, 22% were 70 yrs or older. The most common histological type was adenocarcinoma (46% in Arm A and 41% in Arm B). Updated toxicity data (grade 3 or greater, %) by arms (arm A/arm B) for 106 pts: neutropenia 40/47; febrile neutropenia 8/6, thrombocytopenia 36/34, nausea/vomiting 8/10, esophagitis 32/24, skin rash 2/21 and fatigue 22/17. The median follow up time is 17 months. Preliminary efficacy data by arms (arm A/arm B) for 99 pts: complete or partial response 73% (95% CI 59–83)/71% (95% CI 57–81%), median failure free survival (months) 12.9 (95% CI 8.6–18.0)/10.3 (95% CI 8.7–18.9); 18 month survival 57% (95% CI 41–79)/47% (95% CI 33–67) and median survival (months) 22.3/18.7. Conclusions: The combination of pemetrexed, carboplatin and thoracic radiation has met the protocol-specified criteria for further study. Although it does not appear that the addition of cetuximab confers additional benefit in this setting, further follow-up is necessary. [Table: see text]

A phase II study of trastuzumab-DM1 (T-DM1), a HER2 antibody-drug conjugate (ADC), in patients (pts) with HER2+ metastatic breast cancer (MBC): Final results

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1017-1017
Author(s):  
C. L. Vogel ◽  
H. A. Burris ◽  
S. Limentani ◽  
R. Borson ◽  
J. O'Shaughnessy ◽  
...  
Keyword(s):  
Phase Ii ◽  
Metastatic Disease ◽  
Targeted Delivery ◽  
Phase Ii Study ◽  
Single Agent ◽  
Objective Response ◽  
Metastatic Breast ◽  
Antibody Drug Conjugate ◽  
Metastatic Setting

1017 Background: T-DM1 is an ADC that combines the biological activity of trastuzumab (T) with targeted delivery of a potent antimicrotubule agent, DM1, to HER2-expressing cancer cells. In a phase I study, T-DM1 was administered IV q3w to pts with HER2+ MBC who had progressed on T + chemotherapy. T-DM1 was well-tolerated at the maximum tolerated dose (MTD) of 3.6 mg/kg, with no reports of cardiac toxicity. The confirmed objective response rate (ORR) for the 9 pts with measurable disease treated at the MTD was 44%. The phase II study described here further assesses tolerability and activity of T-DM1. Methods: This was a multi-institutional, open-label, single-arm phase II study, to enroll 100 pts. All eligible pts had progressed on HER2-directed therapy and had received chemotherapy in the metastatic setting. T-DM1 was administered at 3.6 mg/kg IV q3w. Primary objectives were assessment of ORR and of safety and tolerability. Results: As of the August 29, 2008, data-cut, 112 patients had enrolled, with baseline median age 54.5 (range 33–82); ECOG PS 2 or 3, 80%; 68.7% with > 3 sites of metastatic disease; median 3 (range 1–14) prior chemotherapy agents for metastatic disease, median 76.3 weeks prior T, and 55.4% with previous lapatinib. Due to limited F/U, the median number of T-DM1 cycles received was 5 (range 1–16), and 19 of the 107 efficacy evaluable patients had only one post-baseline tumor assessment. Fifty-six pts had discontinued study treatment. With a median follow-up of 4.4 mos, there were 42 (39.3%) ORs (CR or PR), 29 (27.1%) of which have been confirmed by follow-up (F/U) imaging. Among the subgroup of pts who had either >6 months F/U or had discontinued from the study at any time (n = 76) there were 33 ORs (43.4%), 29 (38.2%) of which were confirmed by F/U imaging. The most common grade 3–4 AE was thrombocytopenia (7.1%). Updated data will be presented at the meeting, including updated ORR, 6-month clinical benefit rate, ORR by independent review, progression-free survival, and duration of response. Conclusions: T-DM1 has single-agent activity in pts with previously treated, HER2+ MBC, and is well tolerated at the recommended phase II dose. [Table: see text]

Two-year follow-up of a phase II study on catumaxomab as part of a multimodal approach in primarily resectable gastric cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4095-4095 ◽  
Author(s):  
Carsten Bokemeyer ◽  
Karsten Ridwelski ◽  
Djordje Atanackovic ◽  
Dirk Arnold ◽  
Ewald Woell ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Multimodal Approach ◽  
En Bloc ◽  
Locally Advanced Gastric Cancer ◽  
Number Of Patients

4095^ Background: Perioperative chemotherapy (CT) has demonstrated as survival benefit in locally advanced gastric cancer (GC) in randomized trials. However, the overall cure rate is 30-40% and a significant number of patients are not able to receive the postoperative part of their CT regimen. In Europe, the trifunctional antibody catumaxomab is approved for the treatment of malignant ascites based on a pivotal trial which also included GC patients. A new multimodal approach combining neoadjuvant CT, followed by gastrectomy and intraperitoneal (i.p.) immunotherapy with catumaxomab was assessed in a single-arm multicenter phase II study. We here report 2-year follow-up data. Methods: GC pts (T2/T3/T4, N+/–, M0) received 3 cycles of neoadjuvant fluoropyrimidin/platinum-based CT followed by ’en-bloc’ R0-gastrectomy. Catumaxomab was administered i.p. as intraoperative bolus (10 µg) followed by 4 consecutive 3-hour infusions of 10-150 µg. Primary safety endpoint was the rate of predefined postoperative complications observed during 30 days after surgery. Key efficacy endpoints included disease-free (DFS) and overall survival (OS). Results: The original study data presented at the WCGC in 2011 (Schuhmacher et al.,Ann Oncol (2011) 22(suppl. 5)) showed that the primary endpoint was met and the described application regimen is safe. At time of surgery, 27.8% of patients were stage I, 27,8% of patients were stage II, 22,3% of patients were stage III and 14,8% of patients were stage IV as assessed according to pTNM measures. At 24 months 39/54 (safety analysis set) patients were still alife,14/54 were dead, (one patient lost to follow-up), 24/37 had no progression, only 13/37 patients relapsed (for 2 patients disease status was not recorded). At the 2 year cut off DFS was 56.4% (95% CI: 41–69%), OS was 75% (95% CI: 60–85%). Conclusions: Catumaxomab as part of a multimodal therapy in primarily resectable GC is a feasible option. The 2-year follow up efficacy results show promising data for DFS and OS in a cohort of locally advanced gastric cancer pts.

Phase II Study of Gemcitabine, Cisplatin, and Infusional Fluorouracil in Advanced Pancreatic Cancer

2003 ◽  
Vol 21 (15) ◽  
pp. 2920-2925 ◽  
Author(s):  
B.F. El-Rayes ◽  
M.M. Zalupski ◽  
A.F. Shields ◽  
U. Vaishampayan ◽  
L.K. Heilbrun ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
World Health ◽  
Significant Activity ◽  
Eligibility Criteria ◽  
Probability Of Survival

Purpose: This phase II study was undertaken to determine the efficacy of adding infusional fluorouracil (FU) to the chemotherapy doublet of gemcitabine and cisplatin in patients with advanced pancreatic cancer. Patients and Methods: The eligibility criteria included histologically or cytologically confirmed adenocarcinoma of the pancreas that was either unresectable or metastatic. No prior gemcitabine therapy was allowed. Patients received a combination of gemcitabine 1,000 mg/m2 intravenously (IV) on days 1, 8, and 15; cisplatin 50 mg/m2 IV on days 1 and 15; and FU 175 mg/m2/d from days 1 to 15 by continuous IV infusion. Cycles were repeated every 28 days. Objective tumor response and toxicity were evaluated according to the World Health Organization criteria. Results: A total of 47 patients (median age, 57 years; males, 59%) were enrolled. Sixteen patients had locally advanced (LA) disease, and 31 patients had metastatic disease. A total of 183 cycles of chemotherapy were administered. In patients with metastatic disease (n = 31), the probability of survival at 6 and 12 months was 66% and 34%, respectively. Objective partial response or stable disease was observed in 26% (90% confidence interval [CI], 0.14 to 0.41) and 61% (90% CI, 0.45 to 0.74) of patients, respectively. In patients with LA disease (n = 16), there were three partial responses (19%; 90 CI, 0.07 to 0.39). One patient in this group was successfully resected after FU-based radiotherapy. The most common grade 3 to 4 toxicities were neutropenia (60%), thrombocytopenia (42%), and anemia (26%). Thirteen patients were hospitalized for treatment-related complications. Conclusion: The combination of gemcitabine, cisplatin, and infusional FU has significant activity in patients with advanced pancreatic cancer.

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