Neoadjuvant chemotherapy with docetaxel plus oxaliplatin and S-1 for locally advanced, resectable gastric or gastro-esophageal junction adenocarcinoma: Short-term results from a phase II trial.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 397-397
Author(s):  
Tomono Kawase ◽  
Yukinori Kurokawa ◽  
Noboru Kobayashi ◽  
Atsushi Takeno ◽  
Ryohei Kawabata ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Adverse Events ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Long Term Results ◽  
R0 Resection ◽  
Free Survival

397 Background: In locally advanced, resectable gastric or gastro-oesophageal junction (EGJ) adenocarcinoma, perioperative the docetaxel-based triplet FLOT (fluorouracil plus leucovorin, oxaliplatin and docetaxel) is the standard chemotherapy in Europe. However, there is no evidence of neoadjuvant chemotherapy for resectable gastric cancer in Japan. Therefore, we conducted a phase II trial of neoadjuvant chemotherapy with docetaxel plus oxaliplatin, and S-1 (DOS) for locally advanced, resectable gastric or EGJ adenocarcinoma. Methods: Eligible patients had histologically confirmed gastric or EGJ adenocarcinoma of a clinical Stage III according to the 14th Edition of Japanese Classification of Gastric Carcinoma. DOS was administered for two or three preoperative cycles followed by eight postoperative cycles of S-1. Each 3-week cycle of DOS consisted of docetaxel 40 mg/m2 and oxaliplatin 100 mg/m2 on day 1 plus S-1 80-120 mg/body on days 1 to 14. Primary endpoint was 3-year progression-free survival rate, and secondary endpoints included overall survival, progression-free survival, response rate, histological response rate, R0 resection rate, and adverse events. Results: Of 50 enrolled patients, 48 (37 gastric and 11 EGJ) were eligible for the analysis. 42 (88%) patients completed two or three preoperative cycles of DOS. The most common grade 3-4 adverse events of DOS were neutropenia (69%), leukopenia (56%), diarrhea (19%), and febrile neutropenia (13%). Of 45 patients who underwent gastrectomy, postoperative morbidities (Clavien-Dindo ≥Grade II) occurred in 12 (27%) patients. R0 resection could be achieved in 43 (90%) patients. 12 (27%) and 30 (67%) of 45 patients achieved pathological response rate of Grade2-3 and Grade1b-3, respectively. There was no treatment-related death. Conclusions: Neoadjuvant DOS for locally advanced, resectable gastric or EGJ adenocarcinoma might be favorable. Long-term results will be published in two years. Clinical trial information: 000017652.

Phase II trial of S-1 combined with oxaliplatin (SOX) as neoadjuvant chemotherapy for locally advanced gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 122-122
Author(s):  
L. Chen
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
High Response Rate ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer

122 Background: Previous phase II trial with combination therapy of S-1 plus oxaliplatin (SOX) demonstrated high response rate and well tolerability in patients with untreated advanced gastric cancer. The aim of this phase II trial was to evaluate the efficacy and safety of SOX as neoadjuvant chemotherapy for locally advanced gastric cancer (AGC). Methods: Eligibility criteria included a histologically proven AGC with stage IIIb, IIIc (AJCC 7th edition), at least 1 measurable lesion, no prior chemotherapy, ECOG 0∼2, adequate hepatic, renal, and bone marrow function. Enrolled patients were staged by EUS and CT. The neoadjuvant chemotherapy consisted of 3-4 cycles of oxaliplatin (130 mg/m2) on day 1 and S-1 (80 mg/m2/day) for 14 days with 7 days rest. After chemotherapy, the patients underwent surgery. Results: From Dec 2009 to Sep 2010, 35 patients (IIIb; 19pts, IIIc; 16pts) were enrolled. The median age of the patients was 54.6 years (range; 20-72 y). All patients were available for evaluating the clinical responese and adverse events. The overall response rate was 68.5% (1CR, 23 PR, 9 SD, 2 PD). 32 patients underwent surgical resection. Of them, 27 patients underwent standard D2 surgery and 5 patients had palliative surgery. 25 patients had R0 resection. Postoperative pathological examination showed that most of the surgical patients were in T4a stage. According to Lauren classification, 71.9% patiens (23/32pts) were diffuse type, SOX showed higher respons rate (1CR, 20 PR, 2 SD, RR: 91.3%) among these patients. Major grade 3/4 hematological toxicities were anemia (5.7%), neutropenia (5.7%) and liver dysfunction (8.6%) and non-hematological toxicities were anorexia (5.7%) and vomiting (11.4%). But most of the adverse events were managable. Conclusions: Neoadjuvant chemotherapy with S-1 plus oxaliplatin (SOX) showed high response rate and and R0 resection rate for locally advanced GC, especially for diffuse type patients. All the patients did not have severe toxicity during the process of chemotherapy. This is the preliminary results, and the survival benefit in locally advanced GC patients that respond to SOX neoadjuvant chemotherapy needs to be addressed by a randomized-controlled trial. No significant financial relationships to disclose.

scholarly journals Phase II Study of Lenvatinib in Patients With Progressive, Recurrent or Metastatic Adenoid Cystic Carcinoma

2019 ◽  
Vol 37 (18) ◽  
pp. 1529-1537 ◽  
Author(s):  
Vatche Tchekmedyian ◽  
Eric J. Sherman ◽  
Lara Dunn ◽  
Crystal Tran ◽  
Shrujal Baxi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adenoid Cystic Carcinoma ◽  
Phase Ii ◽  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Free Survival ◽  
Overall Response ◽  
End Point ◽  
Adenoid Cystic

PURPOSE Recurrent or metastatic adenoid cystic carcinoma (R/M ACC) is a malignant neoplasm of predominantly salivary gland origin for which effective therapies are lacking. We conducted a phase II trial evaluating the multitargeted tyrosine kinase inhibitor lenvatinib in patients with R/M ACC. PATIENTS AND METHODS This study was conducted with a two-stage minimax design. Patients with histologically confirmed R/M ACC of any primary site with radiographic and/or symptomatic progression were eligible. Any prior therapy was allowed except previous lenvatinib. Patients received lenvatinib 24 mg orally per day. The primary end point was overall response rate. Secondary end points were progression-free survival and safety. An exploratory analysis of how MYB expression and genomic alterations relate to outcomes was conducted. RESULTS Thirty-three patients were enrolled; 32 were evaluable for the primary end point. Five patients (15.6%) had a confirmed partial response, 24 patients (75%) had stable disease, two patients (6.3%) discontinued treatment as a result of toxicity before the first scan, and one patient (3.1%) had progression of disease as best response. Median progression-free survival time was 17.5 months (95% CI, 7.2 months to not reached), although only eight progression events were observed. Patients otherwise were removed for toxicity (n = 5), as a result of withdrawal of consent (n = 9), or at the treating physician’s discretion (n = 6). Twenty-three patients required at least one dose modification, and 18 of 32 patients discontinued lenvatinib for drug-related issues. The most common grade 3 or 4 adverse events were hypertension (n = 9; 28.1%) and oral pain (n = 3; 9.4%). Three grade 4 adverse events were observed (myocardial infarction, n = 1; posterior reversible encephalopathy syndrome, n = 1; and intracranial hemorrhage, n = 1). CONCLUSION This trial met the prespecified overall response rate primary end point, demonstrating antitumor activity with lenvatinib in R/M ACC patients. Toxicity was comparable to previous studies, requiring monitoring and management.

Phase II trial of oxaliplatin as first-line chemotherapy in metastatic colorectal cancer patients. Digestive Group of French Federation of Cancer Centers.

1998 ◽  
Vol 16 (8) ◽  
pp. 2739-2744 ◽  
Author(s):  
Y Bécouarn ◽  
M Ychou ◽  
M Ducreux ◽  
C Borel ◽  
F Bertheault-Cvitkovic ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Sensory Neuropathy ◽  
Progression Free Survival ◽  
Free Survival ◽  
Duration Of Response ◽  
Grade 3 ◽  
Colorectal Cancer Patients ◽  
Peripheral Sensory

PURPOSE To evaluate the objective tumor response rate and safety profile of oxaliplatin when administered to patients with previously untreated metastatic colorectal adenocarcinoma. PATIENTS AND METHODS A total of 39 patients were entered onto this phase II trial. One patient was excluded for having had a second cancer, so the study was based on 38 patients. Patients were treated with oxaliplatin 130 mg/m2 as a 2-hour infusion on day 1, every 21 days. Patients were assessed for response every three courses. All clinical and radiologic data were reviewed by an external panel of experts, with their assessment being considered definitive. RESULTS Nine partial responses (PRs) were observed (response rate, 24.3%; 95% confidence interval, 11.8% to 41.2%). The median duration of response was 216+ days. Fifteen patients (40.5%) had stable disease and 13 (35.2%) had progressive disease. The median progression-free survival time for all patients was 126+ days (range, 21 to 447+). The main toxicity was peripheral sensory neuropathy. Grade 3 neurotoxicity (National Cancer Institute common toxicity criteria [NCI-CTC]) was reported in 13%. Hematologic and gastrointestinal toxicities were mild. The incidence of grade 3 neutropenia was 5.2%, while that of grade 3 or 4 thrombopenia was 7.9%. Vomiting (grade 3 or 4) occurred in 7.9% of patients and grade 3 diarrhea in 2.6%. CONCLUSION This phase II study provides clear evidence of the safety and efficacy of oxaliplatin monotherapy at this dose and schedule in patients with previously untreated metastatic colorectal carcinoma.

Phase II study of ifosfamide, carboplatin and etoposide (ICE) in recurrent glioblastoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2066-2066
Author(s):  
T. Aoki ◽  
K. Nojima ◽  
T. Mizutani ◽  
M. Ishikawa ◽  
A. Takasu ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Phase Ii Study ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
First Line ◽  
Open Label ◽  
Free Survival ◽  
Secondary Endpoints

2066 Background: To evaluate the efficacy and tolerability of ifosfamide, carboplatin and etoposide ( ICE ) in patients with recurrent glioblastoma. Methods: This was an open-label, single-center phase II trial. Forty-two patients with first recurrent glioblastoma after surgery, standard radiotherapy and a first-line temozolomide-based or ACNU-based chemotherapy, were enrolled.The primary endpoint was progression-free survival at 6 months ( PFS-6 ), and secondary endpoints were response rate, toxicity, and survival. Chemotherapy consisted of Ifosfamide ( 700 mg / m2 on day 1, 2 and 3 ), carbopaltin ( 100 mg / m2 on day 1 ), etoposide ( 70 mg / m2 on day 1, 2, and 3 ), every 6 weeks. Results: PFS-6 was 37 %. The median PFS was 17 weeks. Response rate was 27 %. Adverse events were generally mild ( grade 1 or 2 ) and consisted mainly of alopecia. Conclusions: This regimen is well tolerated and has activity in patients with recurrent glioblastoma. No significant financial relationships to disclose.

scholarly journals Rationale and design of a phase II trial of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study)

2020 ◽  
Vol 12 ◽  
pp. 175883592092784 ◽  
Author(s):  
Tadaaki Yamada ◽  
Junji Uchino ◽  
Yusuke Chihara ◽  
Takayuki Shimamoto ◽  
Masahiro Iwasaku ◽  
...  
Keyword(s):  
Phase Ii ◽  
Antitumor Agents ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Open Label ◽  
Free Survival ◽  
The Pacific ◽  
Secondary Endpoints

Background: In the PACIFIC study, progression-free survival (PFS) and overall survival (OS) of patients with unresectable, locally advanced, stage III non-small cell lung cancer (NSCLC) were prolonged by durvalumab as maintenance therapy after radical concurrent chemoradiotherapy using platinum-based antitumor agents. However, no data were obtained to reveal the efficacy of durvalumab after radiation monotherapy in patients unsuitable for chemoradiotherapy. Here, we describe an ongoing single-arm, prospective, open-label, multicenter phase II trial of durvalumab in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study). Methods: Durvalumab at 10 mg/kg body weight is administered every 2 weeks after radiation therapy until individual patients meet the discontinuation criteria. The treatment duration is up to 12 months. The primary endpoint is the 1-year PFS rate. Secondary endpoints are response rate, PFS, OS, and safety. Durvalumab treatment after radiation monotherapy is expected to prolong 1-year PFS rate and have acceptable adverse events. Discussion: We are conducting an intervention study to investigate the safety and efficacy of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy.

A phase II study of weekly nab-paclitaxel in combination with cisplatin as neoadjuvant chemotherapy in patients (pts) with locally advanced esophageal squamous cell carcinoma (SCC).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 122-122
Author(s):  
Fan Yun ◽  
Xinming Zhou ◽  
Youhua Jiang ◽  
Qixun Chen ◽  
Zhiyu Huang ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Pathological Response ◽  
R0 Resection ◽  
Resection Rate ◽  
Free Survival ◽  
Disease Free

122 Background: This phase II study was aimed to define the pathological response rate and safety of combining weekly nab-paclitaxel and cisplatin as neoadjuvant chemotherapy in pts with locally advanced esophageal SCC. Methods: Pts with resectable locally advanced thoracic esophageal SCC staged by EUS, CT and/or PET-CTscan. All pts received nab-paclitaxel (100 mg/m2, d1, d8, d22 and d29) and cisplatin (75 mg/m2, d1 and d22) as neoadjuvant chemotherapy, followed by esophagectomy.Postoperation: 2 cycles of adjuvant chemotherapy with same regimen was given in 4-6 weeks after the resection.The primary endpoint was pathological response rate. The second endpoints included R0 resection rate,down-staging rate, 3 years overall survival (OS) and disease-free survival (DFS). Results: From 01/2011 to 10/2012, 35 pts were enrolled. 31 male:4 females; IIA/IIB/IIIA/IIIB/IIIC in 3 (8.6%), 5 (14.3%),10 (28.6%), 8 (22.9%) and 9 (25.7%) pts. 30/35 pts went to surgery (85.7%). 30 had R0 resection (100%). Pathological complete response (pCR) was achieved in 4 pts (13.3%). Near pCR (microfoci of tumor cells on the primary tumor without lymph nodal metastases) in 2 pt (6.7%). Down-staging was observed in 19 of 30 patiens (63.3%). 5 pts did not going to surgery: 2 for progressive disease, 3 for refused. 24/30 pts (80.0%) received adjuvant chemotherapy, 7 pts (23.3%) received adjuvant chemoradiotherapy. Grade 3/4 toxicities in 35 evaluable pts during chemotherapy were as follow: neutropenia (11.4%), anemia (8.6%), thrombocytopenia (5.7%), nausea/vomiting (14.3%), neutropenia fever (8.6%), asthenia (20.0%). Surgical complications: 1 anastomotic leaks (3.3%). No treatment-related death. At a median follow up of 12 months (8~20mos), 29 pts were all disease-free survival. Conclusions: In pts with locally advanced esophageal SCC, weekly nab-paclitaxel and cisplatin as neoadjuvant chemotherapy achieved a high pathological response rate and R0 resection rate. The toxicity was well tolerated. Evaluation of nab-paclitaxel and cisplatin in randomized trials was warranted. Clinical trial information: NCT01258192.

Neoadjuvant chemotherapy with modified FOLFOXIRI for locally advanced rectal cancer: A single center phase II trial.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 69-69
Author(s):  
Wen Zhang ◽  
Haitao Zhou ◽  
Jun Jiang ◽  
Yuelu Zhu ◽  
Shuangmei Zou ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Folinic Acid ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Venous Invasion ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
R0 Resection

69 Background: Chemoradiotherapy (CRT) remains the standard treatment choice for locally advanced rectal cancer (LARC). Neoadjuvant chemotherapy alone with doublet mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin) seemed not to influence recurrence free survival with the advantage of less treatment-related complications. This phase II trial was designed to evaluate the efficacy and safety of neoadjuvant triplet chemotherapy with mFOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan) in patients with LARC (NCT03443661). Methods: Patients with LARC received up to 5 cycles of mFOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 were administered on Day 1, fluorouracil 2400 mg/m2 was administered as a continuous intravenous infusion for 48 hours on Day 1, and was repeated every 14 days). Magnetic resonance imaging (MRI) was performed to assess the baseline and post-chemotherapy TN stage. Radical resection was performed within 4–6 weeks of the last dose of chemotherapy if the tumor shrank or remained stable. Adjuvant chemotherapy with mFOLFOX6 or XELOX (oxaliplatin and capecitabine) was recommended. Postoperative radiation was planned for R1 resection, ypT4b, ypN2, and positive circumferential resection margin (CRM). The primary endpoint was the pathological complete response (pCR) rate. Results: Between December 2015 to March 2019, a total of 50 patients were enrolled. 48 (96%) of the patients were clinically node-positive, 28 (56.5%) were CRMnvolved, and 39 (78.4%) were extramural venous invasion (EMVI)-positive. The median cycle of neoadjuvant mFOLFOXIRI chemotherapy was 5 (range, 1–5). A total of 46/50 (92%) patients underwent total mesorectal excision (TME) surgery, all with R0 resection. The pCR rate was 4.3% (2/46). Twenty-three of 46 (50%) patients achieved pathological node-negative status. The proportion of pathologically positive CRM and EMVI were 2.2% and 34.7%, respectively (table). Adjuvant radiotherapy was given to 14/46 (30.4%) patients. The most common Grade 3 or more toxicities included neutrocytopenia (50%), leukopenia (14%), and diarrhea (12%) during neoadjuvant chemotherapy. Clinical meaningful surgical morbidities included pneumonia (n=1), pelvic infection (n=1), and anastomotic fistula (n=1). With a median follow-up time of 33 months (range, 14–73 months), local recurrences and distant metastases were confirmed in 3 (6.5%) and 8 (17.4%) cases, respectively. Conclusions: Neoadjuvant chemotherapy with mFOLFOXIRI yielded a significant down-staging effect with an ordinary pCR rate, and seemed effective in eliminating EMVI and transforming CRM-positive to CRM-negative status in patients with LARC. The preliminary survival results are promising. This regimen could serve as a potential alternative to CRT in selected patients with LARC. Clinical trial information: NCT03443661. [Table: see text]

Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer.

1998 ◽  
Vol 16 (10) ◽  
pp. 3316-3322 ◽  
Author(s):  
H Choy ◽  
W Akerley ◽  
H Safran ◽  
S Graziano ◽  
C Chung ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Combined Modality Therapy ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Free Survival ◽  
Locally Advanced Nsclc

PURPOSE Combined modality therapy for non-small-cell lung cancer (NSCLC) has produced promising results. A multiinstitutional phase II clinical trial was conducted to evaluate the activity and toxicity of paclitaxel, carboplatin, and concurrent radiation therapy on patients with locally advanced NSCLC. PATIENTS AND METHODS Forty previously untreated patients with inoperable locally advanced NSCLC entered onto a phase II study from March 1995 to December 1996. On an outpatient basis for 7 weeks, patients received paclitaxel 50 mg/m2 weekly over 1 hour; carboplatin at (area under the curve) AUC 2 weekly; and radiation therapy of 66 Gy in 33 fractions. After chemoradiation therapy, patients received an additional two cycles of paclitaxel 200 mg/m2 over 3 hours and carboplatin at AUC 6 every 3 weeks. RESULTS Thirty-nine patients were eligible for the study. The survival rates at 12 months were 56.3%, and at 24 months, 38.3%, with a median overall survival of 20.5 months. The progression-free survival rates at 12 months were 43.6%, and at 24 months, 34.7%, with a median progression-free survival of 9.0 months. Two patients did not receive more than 2 weeks of concurrent chemoradiotherapy and were not assessable for toxicity and response. The overall response rate (partial plus complete response) of 37 assessable patients was 75.7%. The major toxicity was esophagitis. Seventeen patients (46%) developed grade 3 or 4 esophagitis. However, only two patients developed late esophageal toxicity with stricture at 3 and 6 months posttreatment. CONCLUSION Combined modality therapy with paclitaxel, carboplatin, and radiation is a promising treatment for locally advanced NSCLC that has a high response rate and acceptable toxicity and survival rates. A randomized trial will be necessary to fully evaluate the usefulness of these findings.

A phase II study of neoadjuvant immunotherapy combined with chemotherapy (camrelizumab plus albumin paclitaxel and carboplatin) in resectable thoracic esophageal squamous cell cancer (NICE study): Interim results.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4060-4060
Author(s):  
Zhigang Li ◽  
Jun Liu ◽  
Ming Zhang ◽  
Jinchen Shao ◽  
Yang Yang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lymph Nodes ◽  
Neoadjuvant Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
R0 Resection ◽  
Grade 3 ◽  
Initial Results

4060 Background: We conducted a phase II trial of preoperative chemotherapy with albumin paclitaxel and carboplatin combined with camrelizumab (NICE regimen), in patients with locally advanced esophageal squamous cell carcinoma (ESCC) with multiple lymph nodes metastasis. Initial results were analyzed to assess the efficacy and safety of this strategy. Methods: This was a prospective, multicenter, open, single arm, phase II trial. Eligible patients were histologically confirmed thoracic ESCC, staged as T1b-4a, N2-3 (≥ 3 stations), and M0 or M1 lymph node metastasis (confined to the supraclavicular lymph nodes) according to the 8th edition of American Joint Committee on Cancer. Patients received neoadjuvant treatment (NICE regimen) with intravenous camrelizumab (200 mg, day 1) plus albumin paclitaxel (100 mg/m2, day 1, 8, 15) and carboplatin (area under curve 5, day 1) of each 21-day cycle, for two cycles before surgery. The primary endpoint is pathological complete response (pCR) rate in the per-protocol population, which included all patients who had tumor resection and received at least one cycle of neoadjuvant treatment. Secondary endpoints include R0 resection rate, adverse events and disease-free survival. Safety was assessed in the modified intention-to-treat population. Results: Of the planned 60 patients enrolled, 55 (91.7%) patients have received the full two-cycles NICE regimen successfully, 4 patients didn’t receive the complete neoadjuvant therapy due to intolerance (3 patients) and drop out (1 patient), 1 patient died due to pneumonia on the second cycle of neoadjuvant therapy. Grade 3-5 treatment-related adverse events (TRAEs) rate was 53.3% and TRAEs resulting in discontinuation rate was 6.7%. The common grade 3-5 TRAEs included lymphopenia (50%), thrombocytopenia (10%), pneumonia (5%) and thyroid dysfunction (3.3%). At the time of writing, 47 patients underwent surgery within 27-85 days (median 36 days) after NICE treatment, in which 7 patients had delays to surgery due to TRAEs. All patients achieved radical (R0) resection. There was no in-hospital and postoperative 30-day mortality. pCR (ypT0N0) was identified in 20 (42.5%) of 47 patients and 5 (10.6%) patients had complete pathological response of the primary tumor but residual disease in lymph nodes alone (ypT0N+). Conclusions: Preoperative NICE regimen has achieved satisfatory initial results of disease response in locally advanced thoracic ESCC. A phase III randomized controlled trial is required to demonstarate the possible survival improvement. Trial registration: ChiCTR1900026240 Clinical trial information: ChiCTR1900026240.

Phase II trial of docetaxel, cisplatin, 5-fluorouracil (TPF) in locally advanced and metastatic squamous cell carcinoma (SCC) of the penis (CRUK/09/001).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 326-326
Author(s):  
Amit Bahl ◽  
Steve Nicholson ◽  
Stephen John Harland ◽  
John D. Chester ◽  
Lisa M. Pickering ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
First Line Therapy ◽  
Neutropenic Sepsis ◽  
Evaluable Population ◽  
Reported Data

326 Background: Chemotherapy for penis cancer is used to palliate metastatic disease and treat locally-advanced disease. Pathologic similarities to head and neck SCC suggest that adding docetaxel (T) to platinum-based regimens may enhance efficacy. Methods: A single-stage single-arm phase II trial was conducted. Eligible patients had measurable, histologically proven penile SCC staged M1; or T4, any N, M0; or any T, N3/inoperable N2, M0; or any T, N1, M0 with Multi-Disciplinary Team agreement for chemotherapy as first-line therapy. Treatment was three 21-day cycles of TPF (day 1: T 75mg/m2, P 60mg/m2; days 1-5: F 750mg/m2/day). In 26 evaluable patients ≥14 responses were required to conclude a response rate of ≥60% (p0=0.35, p1=0.60, α=0.1, β=0.2; Fleming-A’Hern design). Primary endpoint was overall response rate at completion/discontinuation of trial treatment. Secondary endpoints included safety, tolerability, progression-free survival (PFS) and overall survival (OS). Results: 29 patients (median age 61 years) were recruited from 9 UK centres between Sept 2009 and Dec 2010. 8 patients were M1. 17 patients had performance status (PS) 0, 11 PS1, 1 PS2. 3 patients discontinued treatment early for reasons other than progression. Dose reductions/delays were reported for 13 patients. 28 patients have on-treatment toxicity data: 19 (68%) experienced grade 3/4 toxicity, with neutropenia most common (n=13, 46%). 7 patients (25%) experienced febrile neutropenia and/or neutropenic sepsis. 10/26 patients (38.5%, 95% CI: 20.2% - 59.4%) in the evaluable population responded. Twelve month PFS was 39.1% (95% CI: 20.9% - 56.8%; median PFS (all 29 patients/M1/M0): 7.1/ 3.1/ 9.6- months). Twelve month OS was 54.6% (34.9% - 70.6%; median OS (all patients/M1/M0): 13.7/ 6.9/ not reached yet-months). Conclusions: UK clinicians successfully recruited to a multi-centre trial in penis cancer, establishing a network of centres for future studies. Toxic effects of TPF were common but not unexpected. The trial did not reach its target response rate of ≥60% to justify further investigation although PFS and OS in this cohort compares favourably to reported data in literature.

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