Navelbine (NVB) oral (o) with cisplatin (CDDP) as induction and concomitant to radiotherapy (RT): Final results of an international phase II trial in stage III non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7691-7691
Author(s):  
B. Utracka-Hutka ◽  
M. Krzakowski ◽  
M. Provencio ◽  
E. Villa ◽  
M. Codes ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Concomitant Administration ◽  
Oral Formulation ◽  
Radiation Dermatitis ◽  
Stage Iiia ◽  
Combination Methods ◽  
Grade 3 ◽  
Tolerance Ratio

7691 Background: NVB i.v. with CDDP has reported an optimal activity/tolerance ratio when used in combination with RT. The new oral formulation of NVB should be easier to use assuming a similar activity profile. An international phase II trial with NVBo + CDDP as induction followed by NVBo+CDDP+RT was implemented in order to evaluate the efficacy of this combination. Methods: Patients (pts) between 18 and 70 years, with histologically proven untreated locally advanced inoperable stage IIIA/IIIB (supraclavicular LN and pleural effusion excluded) NSCLC, adequate bone marrow, hepatic and renal function, KPS ≥ 80% were treated with NVBo D1,8 60 mg/m2 cycle 1 and 80 mg/m2 cycle 2 (if no haematological/non-haematological grade 3–4 toxicity) and CDDP 80 mg/m2 every 3 weeks for 2 cycles as induction. OR/NC pts received NVBo D1,8 40 mg/m2 and CDDP 80 mg/m2 every 3 weeks for 2 more cycles and RT 66 Gy in 6.5 weeks. Results: Between 12/01 and 12/03 54 pts were enrolled; stages IIIA 48%, IIIB 52%; squamous 59%; median age 57 years (range 41;71), median KPS 100% (range 80; 100%) 7% pts ≥ 5% weight loss at baseline. RDI of NVBo/CDDP were 86%/93% and 97%/98% at induction and in combination with RT, respectively. Forty-one pts (76%) during induction increased NVBo from 60 to 80 mg/m2. Reasons for non- escalation: haematological 7 pts, non-haematological 2, mistake 4. After 2 cycles of CT induction, OR (ITT) in the 54 pts was 37%. Toxicity during induction: G3–4 Neutropenia (28%), febrile neutropenia (7%), G3 nausea (11%), G3–4 vomiting (9%), G3 anorexia (4%) G4 diarrhoea (2%); G3 constipation (2%). Forty-seven out of 54 pts received CT-RT. Median RT delivered dose: 66 Gy. Tolerance: 9% G3 Neutropenia; no G3/4 oesophagitis; 2% G3 radiation dermatitis. Late pulmonary fibrosis 1 pt. One month after CT-RT completion the overall RR (ITT) in the 54 pts was 54% (95% CI: 40%; 67%). Median PFS/OS: 12.5 (95% CI: 9.6; 16.4) /23.4 (95% CI: 17.6; 29.8) months, respectively. Conclusion: NVB Oral with CDDP is effective in stage IIIA/IIIB pts. The excellent tolerance profile allowed to complete the CT/RT treatment in 94% of pts. NVB oral is a new and promising option which facilitates the concomitant administration of CT/RT. [Table: see text]

Adjuvant sunitinib following chemoradiotherapy (CRT) and surgery for esophageal cancer: A phase II trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15550-e15550
Author(s):  
A. M. Horgan ◽  
G. Darling ◽  
R. Wong ◽  
A. Visbal ◽  
M. Guindi ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Systemic Disease ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Thoracic Esophagus ◽  
Curative Intent ◽  
Post Surgery ◽  
Grade 3

e15550 Background: Locally advanced esophageal cancer (LAEC) has a 5-year survival of < 30 %. Most patients (pts) fail after curative intent tri-modality treatment with distant metastatic disease. This phase II trial aims to determine if adjuvant targeted therapy, after neoadjuvant CRT plus surgery for resectable LAEC, may impact on systemic disease without significant toxicity. Methods: Pts with LAEC of the thoracic esophagus or gastroesophageal junction, ECOG PS 0,1 and surgical candidates treated with: preoperative Irinotecan (65mg/m2 initially, ammended to 50mg/m2) + Cisplatin (30mg/m2) on weeks 1,2,4,5,7,8 + concurrent conformal radiotherapy (50Gy/25 fractions) on weeks 4–8. Esophagectomy during weeks 15–18. Sunitinib 37.5mg daily (escalating to 50mg daily if tolerated) commenced 4–12 weeks post surgery, for 1 year. Primary endpoint is feasibility and efficacy of adjuvant sunitinib. Planned sample size 36pts. Results: 30pts enrolled from 11/06 to 12/08. Median age 64 yr (43–71), male: 22, adenocarcinoma: squamous 22:6; 10 pts stage IIA, 5 IIB and 13 III. 2 pts excluded with positive PET scan. 28 pts completed CRT - 18 pts (64%) received ≥80% of planned chemotherapy dose, 23 pts (82%) received full radiation dose. Grade 3/4 toxicity included: neutropenia (17/28), diarrhea (7/28), dehydration (4/28), febrile neutropenia (FN) (3/28) and nausea (2/28). 2 deaths on chemotherapy (1 bacterial meningitis, 1 FN) leading to irinotecan dose- reduction. Dysphagia improved in 14/23 pts during CRT. 18 pts have undergone esophagectomy. Complete pathological response in 4 (22%), downstaging in 3 (17%), stable disease in 11 (61%). 2 pts unresectable (metastases at laparotomy). 1 post-operative death due to pulmonary embolus. 9 pts have commenced sunitinib, 6 maintained at starting dose of 37.5mg; 2 dose reductions; 1 discontinued with poor wound healing. Grade 3 toxicity included: leukopenia (2/9), hand-foot reaction (1/9) and depression (1/9). Conclusions: In LAEC, induction Irinotecan/Cisplatin and radiotherapy followed by esophagectomy is associated with a significant but manageable toxicity profile. Early initiation of sunitinib is feasible and well-tolerated. Updated results to be presented. No significant financial relationships to disclose.

Neoadjuvant bevacizumab (B) and trastuzumab (T) in combination with weekly paclitaxel (P) as neoadjuvant treatment in HER2-positive breast cancer: Results from a phase II trial (AVANTHER).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 602-602
Author(s):  
Maria Fernandez Abad ◽  
Isabel Calvo ◽  
Noelia Martinez ◽  
Mercedes Herrero ◽  
Yolanda Quijano ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
High Rate ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Combination Methods ◽  
Positive Breast Cancer

602 Background: B in combination with T has showed meaningful activity in patients (pts) with metastatic HER2-positive breast cancer. AVANTHER is a Phase II trial of preoperative systemic therapy combining B with T and P in a weekly regimen in HER2 positive breast cancer to assess safety and efficacy of the combination. Methods: Pts with centrally-confirmed HER2-positive (IHC 3+ or FISH positive) breast cancer (stage II or III including locally advanced) received neoadjuvant chemotherapy (NC) with weekly P (80mg/m2/week) for 12 weeks in combination with weekly T (4mg/kg loading dose and 2 mg/kg maintenance) and B (15mg/kg every 3 weeks) for 4 cycles. After surgery all pts received T (1 year) and liposomal doxorubicin plus cyclophosphamide every 3 weeks (4 cycles); primary endpoint was rate of pathological complete response (pCR) in breast and axilla. For all patients, a tissue sample at baseline as well as at surgery was collected for biomarker analyses. Results: A total of 44 pts have been enrolled. Median tumor size: 3.9 cm. Seven (19.4%) pts had stage IIA; 17 (47.2%) stage IIB; 8 (22.2%) stage IIIA and 4 (11.1%) stage IIIB. Twenty-one (58.3%) pts had both positive-hormonal receptors and 10 (27.8%) were hormone receptor negative. Eight (22.2%) pts had sentinel biopsy before NC, being negative in 6 (16.7%) cases. Data from surgery (only from 36 pts): pCR was achieved in 16 (44.4%) pts. Safety and tolerability were good, with rare adverse events of grade ≥3 [1 (2.8%) episode of severe hypertension]. Conclusions: These data show that the combination of P with T and B without an anthracycline for 12 weeks is very effective as NC in HER2 positive breast cancer pts with a high rate of pCR and minimal side effects.

scholarly journals A phase II trial of neoadjuvant doxorubicin plus cyclophosphamide followed by lapatinib plus docetaxel sequential with adjuvant trastuzumab for treatment of early HER2 positive breast cancers

2017 ◽  
Vol 7 (2) ◽  
pp. 28
Author(s):  
Gregory A. Vidal ◽  
Namratha Vontela ◽  
Mary Chen ◽  
Julie M. Ryder ◽  
Struti Sheth ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Breast Conservation ◽  
Breast Cancers ◽  
Her2 Positive ◽  
Adjuvant Trastuzumab ◽  
Skin Reactions ◽  
Grade 3

Background: The use of HER2 targeting therapy has revolutionized the treatment of HER2 positive breast cancers. Here, we investigate whether a sequential approach to dual HER2 blockade of lapatinib followed by trastuzumab will result in improved clinical outcomes.Methods: This was a single institution, open label, single arm, phase II trial in women with HER2 positive breast cancer. Volunteers were treated with sequential neoadjuvant doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) (AC) for 4 cycles followed by docetaxel (100 mg/m2) concurrent with lapatinib (1,250 mg) (TL) daily for 21 days for four cycles before definitive surgery. The primary end point was pathologic complete response (pCR).Results: The study accrued only 21 of the 71 planned patients from 2/28/2007 to 5/25/2010. All patients (100%) experienced down staging. The pCR rate was 41% (7/18). 11 patients had tumor size of T3 or greater, 3 of which experienced pCR and only 1 underwent breast conservation (lumpectomy). The most common hematologic AE (all grades) was anemia 17/21 (81%). There were no incidences of grade 3 or 4 anemia. 10 of 21 (48%) patients experience a non-hematologic grade 3 AE. The most common non-hematologic AEs (all grades) were irregular menses 20/21 (95%) and hand-foot-skin reactions 20/21 (95%). No increase cardiac abnormalities were noted. The DFS at data cut off was 87.5%.Conclusion: The provocative pCR and DFS results in this high risk locally advanced patient population should be viewed with caution given results of the Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation study (ALTTO) clinical trial.

Preoperative Concurrent Chemoradiotherapy in Locally Advanced Rectal Cancer With High-Dose Radiation and Oxaliplatin-Containing Regimen: The Lyon R0–04 Phase II Trial

2003 ◽  
Vol 21 (6) ◽  
pp. 1119-1124 ◽  
Author(s):  
Jean-Pierre Gérard ◽  
Olivier Chapet ◽  
Chantal Nemoz ◽  
Pascale Romestaing ◽  
Françoise Mornex ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
High Dose ◽  
Operative Specimen ◽  
Concomitant Boost ◽  
Grade 3

Purpose: The combination of radiation, fluorouracil, and oxaliplatin in locally advanced rectal cancer has been shown to be feasible in a phase I trial. The purpose of this phase II trial was to assess tolerance and efficacy of this regimen in a preoperative setting. Patients and Methods: Between May 2000 and October 2001, 40 operable patients were entered onto the study. Radiotherapy was delivered with a three-field technique to a dose of 50 Gy over 5 weeks with a concomitant boost approach. Two cycles of chemotherapy were given synchronously on weeks 1 and 5, with oxaliplatin 130 mg/m2 on day 1 followed by 5-day continuous infusion of fluorouracil 350 mg/m2 and l-folinic acid 100 mg/m2. Surgery was planned 5 weeks later. Results: All patients completed treatment without modification except one who experienced grade 3/4 toxicity. Grade 3 toxicity was seen in seven patients. Surgery was performed in all patients after a mean interval time of 5 weeks. An objective clinical response was seen in 30 patients (75%). Sphincter-saving surgery was possible in 26 patients. No postoperative deaths occurred. In four patients (10%), a reoperation was necessary (anastomotic fistula, n = 2; pelvic abscess, n = 2). In six cases the operative specimen was sterilized (15%), and in 12 cases (30%), only few residual cells were detected. Conclusion: Such a combined preoperative chemoradiotherapy and oxaliplatin-containing regimen is well tolerated with no increase in surgical toxicity. The good response rate observed warrants its use in further clinical trials.

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.

A phase II trial of epigenetic therapy with hydralazine and magnesium valproate associated to doxorubicin and cyclophosphamide for locally advanced breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13147-13147
Author(s):  
C. Arce-Salinas ◽  
B. Segura-Pacheco ◽  
T. Vela-Chavez ◽  
E. Bargallo-Rocha ◽  
E. Pérez-Cárdenas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Dna Methylation ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Complete Response ◽  
Epigenetic Therapy ◽  
Antitumor Effects ◽  
Median Size ◽  
Grade 3

13147 Background: DNA methylation and histone deacetylation are the most studied epigenetic alterations in cancer. Hydralazine and magnesium valproate are proven DNA methylation and histone deacetylase inhibitors respectively that in combination exert antitumor effects by their own and potentate the effect of chemotherapy. Methods: Open label two-stage design phase II trial to evaluate safety and efficacy of hydralazine and magnesium valproate plus chemotherapy in terms of pathologic complete response as neoadjuvant treatment. A total of 42 patients will be accrued. Untreated patients with histological confirmation of breast cancer in clinical stage IIb-IIIa, and hematological, renal and hepatic normal function are elegible. Patients with any collagen disease and any cardiovascular condition were excluded. Treatment consisted on four 21-day courses of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 plus epigenetic therapy starting 7 days before the first cycle of chemotherapy and continued until the end of chemotherapy. Oral hydralazine dosed according to acetylator phenotype and magnesium valproate at 30mg/Kg. After chemotherapy patients were evaluated with mammography and then submitted to surgical resection. Results: 17 patients in the first-stage have been accrued. Their characteristics are as follows: Median age 45-y (39–67), 67% were stage IIIa, median size of tumor was 5 cm (3–10 cm). All patients had clinically positive axillary nodes, with median size of 2 cm (1–5 cm), 80% were ductal carcinomas and 80% had either intermediate or high grade; 77% were ER-positive and 30% over-expressed HER2. Hematological toxicity was the most common side effect, neutropenia grade 3/4 was found in 35% of cases, anemia grade 3/4 was present in 15% of cases and most presented transient grade 2 depressed level of consciousness. Seven patients have completed planned treatment, clinical responses were CR 2, PR 4 and SD 1; in 1 of 7 a pathological complete response was seen. Conclusions: Epigenetic therapy with hydralazine and magnesium valproate associated to conventional chemotherapy is well tolerated. Its antitumor efficacy is pending to evaluate. No significant financial relationships to disclose.

Interferon-based chemoradiation as primary therapy for locally advanced pancreatic cancer: A phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15082-15082
Author(s):  
V. J. Picozzi ◽  
N. Boone-Hill ◽  
L. W. Traverso ◽  
R. A. Kozarek
Keyword(s):  
Phase Ii ◽  
Pancreas Cancer ◽  
Phase Ii Trial ◽  
Abdominal Cavity ◽  
Locally Advanced ◽  
Advanced Pancreatic Cancer ◽  
Primary Therapy ◽  
Gi Symptoms ◽  
Grade 3 ◽  
Experienced Grade

15082 Background: Locally advanced pancreas cancer (LAPD) is a therapeutic challenge for clinicians worldwide. Chemoradiation and chemotherapy-only approaches are used, typically producing overall survival (OS) of only 9–14 months (mo). In 1995, we developed a unique chemoradiation method using cisplatin (C), 5-FU (F), and alpha-interferon (IFN) , followed by post-chemoradiation (F). As adjuvant therapy to resected pancreas cancer; this method has produced 5-yr OS of 40%-50% in our institution.We report here a phase II trial assessing the efficacy of this regimen in LAPD. Methods: Patients with LAPD ( non-laparascopy-staged), ECOG performance score 0–1, were treated with XRT 5000cGy/25 fractions simultaneous with (C) 30mg/m2 d 1,8,15,22,29, (F) 200mg/m2 IVCI d 1–35, and (IFN) 3million U SQ qod d 1–35 .(F) 200mg/m2 IVCI was given for 2 additional 6 week cycles (weeks 9–14 and 17–22) . Therapy post- progression was given at the discretion of the treating physician. Results: From 7/1995 and 7/2002, 20 patients(pts) (median age 62) were accrued. 19/20 pts (95%) completed >95% of specified XRT dose; 17/20 pts (85%) received >80% of specified chemotherapy doses during XRT. 12/20 pts (60%) completed >80% of specified (F) post chemoradiation. 10/20 pts (50%) experienced grade 3 toxicity during chemoradiation, and 10/20 pts (50%) required hospitalization including 4-GI symptoms (e.g.diarrhea/dehydration), 2-GI bleeding, 2-fever, 1-hyponatremia and 1-anorexia. No grade 4 toxicities and no toxic deaths occurred. All 20 pts have now expired. Initial site of disease progression was liver 8 pts, abdominal cavity 4 pts, local 4 pts, unknown 4 pts. Median time to progression was 7 mo; median OS was 12.5 mo (range 3–51 mo). 1-and 2-yr OS were 55% and 20%, respectively. 7/20 pts. received gemcitabine-based regimens following tumor progression; median OS of these pts was 17 mo. Conclusions: 1) The IFN-based chemoradiation described above is moderately severe in toxicity, but can be successfully applied to LAPD. 2) This chemoradiation method may be a sucessful platform for the treatment of LAPD with gemcitabine-based chemotherapy. Studies investigating this approach are presently underway at our institution. No significant financial relationships to disclose.

Phase II trial combining atezolizumab concurrently with chemoradiation therapy in locally advanced non-small cell lung cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 8512-8512 ◽  
Author(s):  
Steven H. Lin ◽  
Yan Lin ◽  
Isabel Mok ◽  
Jenean A. Young ◽  
See Phan ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Cancer Recurrence ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Chi Square ◽  
Tumor Biopsy ◽  
Chi Square Test ◽  
Grade 3

8512 Background: Consolidation durvalumab after chemoradiation (CRT) is the new standard of care in locally advanced NSCLC (LA-NSCLC). We hypothesized that adding immunotherapy concurrently with CRT (cCRT) would increase efficacy without significant additive toxicity. To test this concept, we conducted a phase II trial called DETERRED combining atezolizumab (atezo) with cCRT followed by consolidation full dose carboplatin/paclitaxel (CP) with atezo (CP-atezo) for 2 cycles and then maintenance atezo for 1 year. The primary endpoint was safety/toxicity and feasibility. Methods: This study enrolled patients (pts) between February 2016 - April 2018 and was done in two parts: In part 1 (N=10), conventionally fractionated CRT (60-66 Gy in 30-33 fractions combined with weekly low dose CP) was followed by CP-atezo then maintenance atezo. Part 2 was cCRT (N=30) with atezo followed by CP-atezo then maintenance atezo. Atezo was given at 1200 mg IV Q3 weeks. Severe adverse events (SAEs) ≥ grade 3 were defined by CTCAE v5.0. Evaluable pts received at least one dose of atezo. PD-L1 staining utilizes the DAKO 22C3 platform. Kaplan Meier were analyzed for progression free survival (PFS) and overall survival (OS), and chi-square test for PD-L1 levels on any recurrence, with significance set at <0.05. Results: In Part 1, atezo related SAEs were seen in 4 pts (40%) (2 grade 3 arthralgia, 1 grade 3 dyspnea and 1 grade 5 TE fistula). Grade 2 radiation pneumonitis (RP) was seen in 1 pt. In Part 2, seven (23%) pts had atezo related SAEs (diarrhea, nephritis, dyspnea, fatigue and heart failure). RP was seen in 3 pts, 2 grade 2 and 1 grade 3, which led to atezo discontinuation. In Part 1, with an overall median follow up (f/u) time of 22.5 months and 27.4 months for survivors, the 1-year PFS is 50%, and OS is 79%. In part 2, with a median f/u time of 11.8 months and 13.7 months for survivors, the 1-year PFS was 57%, and OS is 79%. Baseline tumor biopsy PD-L1 status was evaluable for 34 pts. There were no significant differences in cancer recurrence for PD-L1 <1% (7/16=44%) vs ≥1% (6/18=33%), or for the PD-L1 cutoff of <50% (11/26=42%) vs ≥50% (2/8=25%). Conclusions: Concurrent atezo with CRT followed by CP-atezo and maintenance atezo is safe without increased toxicities compared to CRT alone followed by CP-atezo and maintenance atezo. Updated efficacy results from DETERRED will be presented. Ultimately, the clinical benefit of immunotherapy with cCRT followed by consolidation chemo-immunotherapy will need to be compared to the PACIFIC regimen in a larger randomized trial. Clinical trial information: NCT02525757.

Phase II Trial of Weekly Paclitaxel for Unresectable Angiosarcoma: The ANGIOTAX Study

2008 ◽  
Vol 26 (32) ◽  
pp. 5269-5274 ◽  
Author(s):  
Nicolas Penel ◽  
Binh Nguyen Bui ◽  
Jacques-Olivier Bay ◽  
Didier Cupissol ◽  
Isabelle Ray-Coquard ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Dose Schedule ◽  
Weekly Paclitaxel ◽  
Curative Intent ◽  
Free Survival ◽  
Grade 3

Purpose The objective of this phase II trial was to assess the efficacy and toxicity of weekly paclitaxel for patients with metastatic or unresectable angiosarcoma. Patients and Methods Thirty patients were entered onto the study from April 2005 through October 2006. Paclitaxel was administered intravenously as a 60-minute infusion at a dose of 80 mg/m2 on days 1, 8, and 15 of a 4-week cycle. The primary end point was the nonprogression rate after two cycles. Results The progression-free survival rates after 2 and 4 months were 74% and 45%, respectively. With a median follow-up of 8 months, the median time to progression was 4 months and the median overall survival was 8 months. The progression-free survival rate was similar in patients pretreated with chemotherapy and in chemotherapy-naïve patients (77% v 71%). Three patients with locally advanced breast angiosarcoma presented partial response, which enabled a secondary curative-intent surgery with complete histologic response in two cases. One toxic death occurred as a result of a thrombocytopenia episode. Six patients presented with grade 3 toxicities and one patient presented with a grade 4 toxicity. Anemia and fatigue were the most frequently reported toxicities. Conclusion Weekly paclitaxel at the dose schedule used in the current study was well tolerated and demonstrated clinical benefit.

Adjuvant Chemotherapy for Resected Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction, and Cardia: Phase II Trial (E8296) of the Eastern Cooperative Oncology Group

2004 ◽  
Vol 22 (22) ◽  
pp. 4495-4499 ◽  
Author(s):  
Mary Armanios ◽  
Ronghui Xu ◽  
Arlene A. Forastiere ◽  
Daniel G. Haller ◽  
John W. Kugler ◽  
...  
Keyword(s):  
Survival Rate ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Positive Outcome ◽  
Lymph Node Involvement ◽  
Distal Esophagus ◽  
Node Involvement ◽  
Grade 3

Purpose To evaluate the effect of postoperative paclitaxel and cisplatin on 2-year survival in patients with completely resected adenocarcinoma of the distal esophagus, gastro-esophageal (GE) junction, and cardia. Patients and Methods We conducted a multicenter phase II trial. Patients had pathologically staged T2 node-positive to T3-4, any node status adenocarcinoma of the distal esophagus, GE junction, or gastric cardia with negative margins (R0). Treatment consisted of four cycles of paclitaxel 175 mg/m2 intravenously (IV) over 3 hours followed by cisplatin 75 mg/m2 IV every 21 days. A positive outcome was considered to be an improvement in 2-year survival rate by ≥ 20% compared to historic controls. Results Fifty-nine patients were recruited from 20 centers. Of 55 eligible patients, 49 (89%) had lymph node involvement. Forty-six patients (84%) completed all four cycles. Of the total 59 patients, 31 (56%) developed grade 3 or 4 toxicity with leukopenia/neutropenia, nausea/vomiting, and metabolic toxicities were most common. The median follow-up for surviving patients was 4 years. At 2 years, 33 patients were alive and 22 were dead, with a survival rate of 60% (95% CI, 46% to 73%; one-sided P = .0008 compared with the historic controls). Conclusion Our data suggest that adjuvant paclitaxel and cisplatin may improve survival in R0 resected patients with locally advanced adenocarcinoma of the distal esophagus, GE junction, and cardia. These results warrant further testing in randomized trials.

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