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PubMed2005

Pathologic response and toxicity assessment of chemoradiotherapy with cisplatin versus cisplatin plus gemcitabine in cervical cancer: a randomized Phase II study.

PURPOSE: To compare gemcitabine and cisplatin (GC) with cisplatin (C) concurrent with radiotherapy in International Federation of Gynecology and Obstetrics Stage IB2, IIA, and IIB cervical carcinoma in a preoperative setting. The main endpoints were the pathologic response rate and toxicity. METHODS AND MATERIALS: A total of 83 patients were randomized to either C or GC. Treatment consisted of six doses of cisplatin at 40 mg/m(2) every week for Arm 1 (C) and six doses of gemcitabine at 125 mg/m(2) plus cisplatin at 40 mg/m(2) every week for or Arm 2 (GC) Both regimens were administered concurrent with 50 Gy of external beam radiotherapy in 2-Gy fractions for 5 weeks. After chemoradiotherapy, patients underwent radical hysterectomy. RESULTS: All 83 patients were studied for toxicity and 80 for response. The complete pathologic response rate in the C arm and GC arm was 55% (95% confidence interval, 35.5-73%) and 77.5% (95% confidence interval, 57-90%; p = 0.0201). Among those with a partial response, 7 patients each had high and intermediate-high risk factors for recurrence in their surgical specimens in the C arm vs. 2 and 3 patients, respectively, with these characteristics in the CG arm. The number of weekly doses and the dose intensity of GC were lower than for C. The time to complete external beam radiotherapy also favored the C arm. The CG combination produced greater GI and hematologic toxicity. CONCLUSION: The radiosensitizing combination of GC achieved a greater pathologic response rate than C in the treatment of cervical cancer.

Adult↗
PubMed2002

Assessing the predictive value of clinical complete response to neoadjuvant therapy for rectal cancer: an analysis of 488 patients.

BACKGROUND: Patients with transmural or node-positive rectal cancer benefit from the addition of chemoradiation to surgical resection. Administration of the chemoradiation (combined modality therapy) preoperatively has gained popularity in recent years. Some patients undergo apparent complete tumor regression after preoperative combined modality therapy, and controversy exists about the proper management of these patients. Some investigators have proposed that such patients should simply be observed and not undergo resection. STUDY DESIGN: The purpose of this study was to determine the significance of clinical complete response to preoperative combined modality therapy. Specifically, we have attempted to determine the frequency with which a clinical complete response (based on the absence of detectable tumor on preoperative digital rectal examination and proctoscopy) correlates with a pathologic complete response (based on the absence of cancer cells in the resected specimen). A retrospective review of the clinical and pathologic characteristics of 488 patients from the Memorial Sloan-Kettering prospective colorectal database who received preoperative chemoradiation followed by resection for primary rectal cancer was performed. The indications for preoperative therapy included clinical or ultrasound T3 or T4 tumors or node-positive disease. RESULTS: The clinical complete response rate to preoperative therapy was 19%. All patients underwent resection subsequent to preoperative therapy regardless of response. The pathologic complete response rate among all patients was 10%. The pathologic complete response rate among clinical complete responders was 25%. Clinical complete response was a significant predictive factor for pathologic complete response, but the majority (75%) of clinical complete responders had persistent foci of tumor that were not detectable on preoperative examination or proctoscopy. CONCLUSIONS: Clinical complete response to preoperative therapy as determined by preoperative digital rectal examination and proctoscopy or EUA is not an accurate predictor of pathologic complete response. A significant percentage of clinical complete responders have persistent deep tumors or nodal involvement. We do not recommend making treatment decisions based solely on the absence of clinically palpable or visible tumor after chemoradiation. Our data suggest that all acceptable-risk patients with a diagnosis of primary rectal cancer should undergo resection, regardless of their response to preoperative therapy.

Adult↗
PubMed1991

Concomitant cisplatin and hyperfractionated external beam irradiation for advanced malignancy of the head and neck.

The combination of cisplatin and hyperfractionated external beam irradiation (HEBI), followed by salvage surgery when indicated, was evaluated in patients with advanced stage squamous cell carcinoma of the head and neck. Thirty patients with stage III (n = 5) or IV (n = 25) disease received intravenous cisplatin 100 mg/m2 by 6-hour continuous infusion on days 1, 21, and 42 of HEBI. Radiation fractions of 110 cGy were given twice daily, separated by 4 to 6 hours, beginning within 12 hours after cisplatin delivery. Doses to the primary site ranged from 60 to 76.35 Gy (median: 72.3 Gy), with 60 to 74 Gy to nodal sites. Follow-up ranged from 4 to 28 months (median: 19 months). Clinical complete response of the primary site was seen in 27 of 29 patients (93%), and complete clinical clearance of adenopathy in 20 of 26 (76%). A second biopsy 6 to 8 weeks after completion of treatment showed residual disease in both the primary and nodal sites in three patients, and in only the primary site in one patient. Four patients with persistent adenopathy had pathologic confirmation at surgery. Four patients had recurrence after negative biopsy results 6 to 9 months after treatment biopsy. At present, with median follow-up of 19 months, eight patients (26%) have died secondary to uncontrolled primary or nodal disease. Two patients have died of nonrelated causes. Overall, 10 of 30 patients (66%) remain alive with no evidence of disease. Mucositis and weight loss were the most common side effects of treatment. Seven patients developed significant xerostomia, and four have cisplatin-related hearing loss requiring amplification. The early evidence of excellent response (89% pathologic complete response of primary sites; 78% complete response of nodal sites), coupled with acceptable treatment morbidity, warrants further study of this approach.

Adult↗
PubMed2005

Cytotoxic and antiproliferative activity of the single agent epirubicin versus epirubicin plus tamoxifen as primary chemotherapy in human breast cancer: a single-institution phase III trial.

This study was designed to address whether simultaneous primary chemo-hormonal therapy provides additional activity compared with chemotherapy alone in breast cancer patients with operable or locally advanced disease. Between January 1997 and January 2002, 211 consecutive patients with T2-4, N0-1, M0 breast cancer were randomized to receive either epirubicin alone (EPI) or epirubicin plus tamoxifen (EPI-TAM). Ki67 expression was evaluated immunohistochemically in tumor specimens obtained before chemotherapy by incision biopsy and at definitive surgery. Tumor shrinkage of >50% was obtained in 76% of patients randomized in the EPI arm and 81.9% of patients randomized in the EPI-TAM arm (not significant). The corresponding rates of clinical and pathological complete response were 20.2 and 21.9% (not significant), and 4.8 and 6.7% (not significant), respectively. Pathologically complete response was more frequently observed in estrogen receptor (ER)-negative (ER-) tumors (P=0.04) and correlated with elevated baseline Ki67 expression (P<0.01). Both EPI and EPI-TAM treatments resulted in a significant reduction in Ki67 expression, either in overall patients (P=0.000) or in patients with ER+ breast cancer (P=0.000). The reduction in Ki67 immunostaining in the EPI-TAM arm was greater than in the EPI arm, leading to a lower Ki67 expression at post-operative residual histology (P=0.0041). The addition of tamoxifen to epirubicin chemotherapy did not improve the response rate but led to a significantly higher reduction in the Ki67 expression. Baseline elevated Ki67 expression and the ER- status were both associated with a greater chance of obtaining a pathological complete response at residual histology.

Adult↗
PubMed1998

A phase II trial of cisplatin and 5-fluorouracil in adenocarcinoma of the oesophagus.

The effect of brief neoadjuvant chemotherapy in patients with apparently operable adenocarcinoma of the oesophagus has been investigated. Two courses of cisplatin and 5-fluorouracil (CFu) were given, followed by evaluation of the response by barium swallow. Twenty-one of 23 patients completed both courses. Two showed a complete response and five a partial response. In only one patient was there a pathological complete response. Toxicity was mild and consisted principally of nausea and vomiting. All patients underwent surgical exploration; resection was completed in 17. There were three hospital deaths (18%). Although CFu has produced two complete responses (on barium swallow) and one complete pathological clearance of tumour, the disappointing total response rate of 7/21 (33%; 95% CI 13-53) or 7/23 (30%; 95% CI 12-49) leads us to believe that further Phase II trials are needed to identify more efficacious agents and regimens.

Adenocarcinoma↗
PubMed1995

Phase I/II study of neoadjuvant intraarterial chemotherapy with mitomycin-C, vincristine, and cisplatin in patients with stage IIb bulky cervical carcinoma.

BACKGROUND: Stage IIb bulky cervical carcinomas have been considered difficult to treat successfully by radiation and/or surgery, compared with smaller lesions. This study was designed to evaluate the efficacy of neoadjuvant pelvic intraarterial chemotherapy (IAC) and to determine the optimal dosage of cisplatin for reducing tumor volume in these patients. METHODS: Twenty-one previously untreated patients with primary cervical carcinoma of more than 4 cm in greatest dimension and parametrial invasion were included in this study. Pelvic IAC was administered using a combination of mitomycin-C, 10 mg/m2; vincristine, 1 mg/m2; and cisplatin, 50 mg/m2 (MVC; group 1, 8 patients) or 75 mg/m2 (group 2, 13 patients). Tumor volumes were measured three-dimensionally by magnetic resonance imaging (MRI) before and after three courses of IAC. Clinical responses were evaluated with gynecologic examination and MRI; pathologic responses were evaluated with histologic examinations of surgical specimens. RESULTS: The mean volume reduction rate (74.2% vs. 97.2% in groups 1 and 2, respectively, P = 0.0022), the clinical complete response rate (0% vs. 69.2%, P = 0.0033), and the pathologic complete response rate (0% vs. 46.2%, P = 0.0445) were significantly higher in group 2. Type III radical hysterectomy was possible in 19 patients (90.5%). Toxicities of grades 2-3 (World Health Organization criteria) were nausea and/or vomiting (38.1%), leukopenia (33.3%), and fever (14.2%). CONCLUSIONS: These preliminary results suggest that neoadjuvant pelvic IAC with MVC (especially with cisplatin at a dose of 75 mg/m2) is effective in reducing tumor volume, increasing the clinical and pathologic complete response rate, and improving the operability in most patients with Stage IIb bulky cervical carcinoma, generally considered inoperable.

Adult↗
PubMed1991

Chemotherapy with high dose ifosfamide/mesna plus cisplatin for the treatment of ovarian cancer: a study of the Grupo de Estudio y Tratamiento Latino-Americano del Cancer.

Twenty-one evaluable patients with FIGO stages II-IV epithelial ovarian cancer, median age 57 (range 47-75 years), were treated with ifosfamide (IF), 3 g/m2 diluted in 500 ml saline solution, 8 hour intravenous (i.v.) infusion on days 1-5; mesna 20% of IF dose, i.v. bolus injection, was given at hours 0 and 4; mesna 40% of IF dose by oral route at hours 8 and 12, days 1-5; plus cisplatin 20 mg/m2 diluted in 500 ml saline solution, 2 hour i.v. infusion, days 1-5. Cycles were repeated every 4 weeks. All patients had metastatic lesions (mesentery, pleura, colon, cervix, abdominal wall, lung, liver, bladder, and nodes). Toxicity ranged from mild to moderate. All patients experienced alopecia, nausea, and vomiting. Neutropenia and anemia ranged from mild to moderate. One patient experienced mild brain confusion and two patients microscopic hematuria. Ten clinically complete responses (47%) and five clinically partial responses (23%) were registered, for an overall 70% objective response. However, after a second look performance in 10 patients with clinically complete response, six of 10 patients showed a pathological complete response and four showed pathological partial response. The median duration of complete response is about 33 months, and median partial response duration is 14 months. Although the numbers are small, these data indicate that combination chemotherapy with high dose ifosfamide/mesna plus cisplatin may be an active treatment for advanced ovarian carcinoma.

Aged↗
PubMed2004

[Chemoradiotherapy followed by surgery in treatment of locally advanced esophageal carcinoma: a phase II trial].

BACKGROUND & OBJECTIVE: Recently, neoadjuvant therapy has become the focus of interest in an effort to prolong survival and reduce recurrence rates in patients with oesophageal cancer. This study was designed to evaluate the tolerance and the short-term outcome of chemoradiotherapy followed by surgery for patients with locally advanced esophageal squamous carcinoma, to observe effects of chemoradiotherapy on tumor resection rate, incidence of complications after surgery, and perioperative mortality. METHODS: From January 2000 to September 2003, Thirty-four consecutive patients with locally advanced esophageal squamous carcinoma were entered into this phase II study. The clinical pre-treatment staging of the tumors were determined by chest CT scan, abdomial CT Scan, EUS, and bronchoscopy examination. Chemotherapy and radiotherapy were performed concurrently. The chemotherapy consisted of Vinorelbine (or 5-Fluorouracil) and Cisplatin. 5-Fluorouracil at 2.4 g/m(2) was administered in continuous infusion for days 1-3 and days 22-25. Vinorelbine at 25 mg/m(2) per day was administered in bolus infusion on d1, d8, d22 and d29. Cisplatin at 75 mg/m(2) was administered by intravenously infusion on d1 and d22. A total radiotherapy dose of 40 Gy was delivered in 20 daily fractions of 2.0 Gy each (given 5 d/wk for 4 weeks). After completion of chemoradiotherapy, clinical restaging was performed. Esophagectomy and lymphadenectomies were performed 3-5 weeks after chemoradiotherapy. RESULTS: Thirty-three patients completed the planned chemoradiotherapy, and 32 patients underwent surgery. The toxicities of chemoradiotherapy such as myelotoxicity, pulmonary toxicity, esophagitis were grade I or II. No death was resulted from chemoradiotherapy. The clinical response rate of chemoradiotherapy was 85.3%, the pathological complete response rate was 25%, the resectability rate was 100%. Postoperative pulmonary infection occurred in 8 patients (22.9%), anastomotic leak in 3 patients (9.4%). Two patients (6.3%) died perioperatively because of ARDS and anastomotic leak complicated with heart failure. CONCLUSIONS: The short-term results of this study suggest that the strategy of chemoradiotherapy followed by surgery is safe,although it caused considerable toxicity and increased operation-related complications rate and perioperative mortality rate compared with surgery alone at the same period. Preoperative chemoradiotherapy is able to significantly reduce the tumor stage, and achieve substantially high clinical response rate and pathological complete response rate.

Adult↗
PubMed2003

Weekly docetaxel as neoadjuvant chemotherapy for stage II and III breast cancer: efficacy and correlation with biological markers in a phase II, multicenter study.

PURPOSE: This is one of the first reports of weekly docetaxel (Taxotere) in the neoadjuvant treatment of stage II and III breast cancer. We evaluated docetaxel's efficacy and safety and analyzed correlations between response and the expression of c-erbB2, ER status, and Ki-67 labeling index. EXPERIMENTAL DESIGN: Patients with previously untreated, stage II and III breast cancer were entered into the study. Docetaxel (40 mg/m(2)) was given i.v. once weekly for the first 6 weeks of an 8-week cycle for 2 cycles. RESULTS: A total of 56 patients were evaluated by intention-to-treat analysis for efficacy and safety. The overall clinical response rate was 68% (complete and partial response, 29 and 39%, respectively). Nine patients (16%) achieved a pathological complete response. There was no correlation between response to docetaxel and the expression of molecular markers, however, the majority of the pathological complete responses were observed in patients with c-erbB2-negative tumors. Nonhematological toxicity was more common than hematological toxicity, with alopecia and asthenia the most frequently reported adverse events (89 and 77% of patients, respectively). Severe hematological toxicity was rare. CONCLUSIONS: Weekly docetaxel appears to be very effective in the neoadjuvant setting. A high pathological response rate was achieved with tolerable toxicity.

Adult↗
PubMed2002

A phase II study of neoadjuvant biochemotherapy for stage III melanoma.

BACKGROUND: Phase II studies of biochemotherapy (combining interleukin-2, interferon-alpha, and multiagent chemotherapy) have reported high response rates and a significant number of durable complete responses in patients with metastatic melanoma. METHODS: A pilot Phase II study was performed to explore the safety and activity of neoadjuvant biochemotherapy in patients with Stage III melanoma. Forty-eight patients were enrolled between April 1996 and May 1999. The median age of the patients was 46 years (range, 19-70 years). Two cycles of biochemotherapy were administered prior to and after complete lymph node dissection. Each cycle was comprised of cisplatin, 20 mg/m2 intravenously (i.v.), on Days 1-4; vinblastine, 1.6 mg/m2 i.v., on Days 1-4; dacarbazine, 800 mg/m2 i.v., on Day 1; interleukin-2, 9 x 10(6) IU/m2/day i.v. over 24 hours, on Days 1-4; and interferon-alpha, 5 x 10(6) IU/m2/day subcutaneously, on Days 1-5, every 3 weeks. Twelve patients did not have measurable disease. All patients were evaluable for toxicity and survival. RESULTS: Clinical responses were observed in 14 of 36 patients (38.9%) with measurable disease, including 13 partial responses (36.1%) and 1 complete response (2.8%). Complete pathologic responses were noted in 4 patients (11.1%). Toxicity, although severe, was manageable and typically short-lived. There were no treatment-related deaths reported. At a median follow-up of 31 months, 38 of the 48 patients (79.2%) were alive and 31 patients (64.6%) remained free of disease progression. CONCLUSIONS: Neoadjuvant biochemotherapy appears to have promising activity in patients with Stage III melanoma. A larger multicenter study currently is underway to explore this approach further.

Adult↗
PubMed1998

Surgical considerations in preoperative chemotherapy of breast cancer.

Primary systemic chemotherapy for breast cancer was initially directed at downsizing tumors to make them acceptable candidates for breast-conserving surgery. Later trials used this approach in the hope of improving disease-free survival and overall survival. Results from NSABP protocol B-18 indicate significant initial tumor response and downstaging of lymph nodes in 30% of patients. Patients with small tumors were more likely to experience complete clinical response and complete pathologic response. Patients with larger tumors whose surgeons would have chosen mastectomy often responded with tumor decrease to a size at which lumpectomy was considered feasible. The local recurrence rate in these patients was higher than in those patients selected for lumpectomy primarily. Nevertheless, even with a higher rate of ipsilateral breast tumor recurrence, approximately 90% of women older than 50 years and 83% of younger women had successful breast-conserving surgery. There was no difference in disease-free survival or overall survival between preoperative and postoperative chemotherapy groups. The response of patients to initial chemotherapy can be a useful tool in exploring the biology of breast cancer.

Breast Neoplasms↗
PubMed2004

A multicenter phase II study of cisplatin and docetaxel (Taxotere) in the first-line treatment of advanced ovarian cancer: a GINECO study.

PURPOSE: A multicenter phase II study to evaluate the antitumor effect and safety of docetaxel in combination with cisplatin as first-line chemotherapy for advanced ovarian cancer. METHODS: Enrolled in the study were 45 patients who were to receive six courses of docetaxel 75 mg/m(2) plus cisplatin 75 mg/m(2) every 21 days with hydration and steroid prophylaxis after initial debulking surgery. Imaging techniques and radiography were used to assess clinical tumor response, and second-look surgery was required for patients with complete clinical responses and for those without clinically measurable disease. RESULTS: The overall clinical response rate in 29 patients with clinically measurable disease was 58% (41% complete response). A complete pathologic response was seen in 9 of 34 patients who underwent second-look laparotomy, while microscopic disease was found in 10 patients. The median time to progression was 14.4 months (95% CI 8.4-20.4 months), with a median overall survival of 43 months (95% CI 21.1-65.0 months). Patients received a median number of six cycles at a dose intensity of 98%. Grade 3-4 neutropenia was seen in 80% of patients, but was manageable. No patients withdrew because of fluid retention. CONCLUSIONS: The combination of docetaxel with cisplatin confers high clinical and pathologically verified tumor response rates and is well tolerated in the first-line management of advanced ovarian cancer.

Adenocarcinoma↗
PubMed2001

Gene therapy approaches for the management of non-small cell lung cancer.

Targeting the specific genetic lesions responsible for carcinogenesis and cancer progression is an attractive strategy for developing more effective anticancer therapies and reducing treatment-related toxicity. The restoration of defective tumor suppressor gene pathways by replacement of tumor suppressor genes in cancer cells has been studied in lung cancer. The most extensively studied agent is the wild-type p53 tumor suppressor gene delivered by an adenoviral vector. Clinical trials to date in non-small cell lung cancer and head and neck cancer have consistently shown evidence of gene transduction and expression, mediation of apoptosis, and clinical responses including pathologic complete responses. However, it also is clear that this approach can be improved. Promising avenues for investigation include improved gene delivery systems, induction of bystander effects, and adjuvant use of gene therapy with conventional chemotherapy, radiation therapy, and surgery. However, these strategies will need further refinement to succeed clinically. This review examines several important issues in cancer gene therapy in general and the most recent achievements in gene therapy for non-small cell lung cancer.

Animals↗
PubMed2003

Current status of gene therapy for lung cancer and head and neck cancer.

Targeting the specific genetic lesions responsible for carcinogenesis and cancer progression is an attractive strategy for developing more effective anticancer therapeutics and reducing treatment-related toxicity. The restoration of defective tumor suppressor gene pathways by replacement of tumor suppressor genes in cancer cells has been studied in lung cancer and head and neck cancer (HNC). The most extensively studied agent is the wild-type p53 tumor suppressor gene delivered by an adenoviral vector. Clinical trials to date in non-small cell lung cancer and HNC have consistently shown evidence of gene transduction and expression, mediation of apoptosis, and clinical responses including pathological complete responses. It is also clear, however, that this approach can be improved further. Promising avenues for investigation include improved gene delivery systems, induction of bystander effects, design of immunogene and antiangiogenesis gene therapies, and adjuvant use of gene therapy with conventional chemotherapy, radiation therapy, and surgery. These strategies, however, will need further refinement to succeed clinically. This review examines several important issues in cancer gene therapy in general and the most recent achievements in gene therapy for HNC and non-small cell lung cancer.

Animals↗
PubMedDate not supplied

The predictive value of clinical evaluation of response to neoadjuvant chemoradiation therapy for rectal cancer.

INTRODUCTION: Multimodality therapy has become the standard treatment for patients with locally advanced (T3 and T4) rectal carcinoma. Accurate preoperative staging of the patients with rectal cancer has increased in importance because the selection of patients with transmural rectal cancer (T3 or T4) or node-positive disease leads to a previous nonsurgical neoadjuvant treatment. The purpose of this study was to evaluate the predictive value of the clinical response to neoadjuvant therapy on the basis of pathological results obtained on rectal cancer patients treated by chemoradiotherapy and surgery. METHODS: From 1994 to 2003, 58 patients with a primary diagnosis of rectal cancer were studied at our department and enrolled in a neoadjuvant protocol of chemoradiotherapy followed by surgery. All patients were treated by 30 days of chemoradiotherapy. At the end of the chemoradiotherapy, each patient underwent clinical examination, including digital rectal examination, proctoscopy and abdominal-pelvic computerized tomography to define the clinical response to the chemoradiotherapy. Surgical resection was performed in all patients three weeks after the end of chemoradiotherapy, and histological analysis was performed on all resected specimens. RESULTS: The clinical complete response rate corresponded to the pathological complete response rate, whereas the clinical evaluation overestimated partial response and stable disease. The pathologic examination revealed that 3.5% of clinical partial responses and 3.4% of clinical stable disease were really pathological progressive disease. Clinical partial response and clinical stable disease positive predictive values were 92.8% and 90.9%, respectively, whereas the clinical progressive disease negative predictive value was 20%. Then, 6.9% of patients believed to have responded to the therapy, or not to have responded or worsened, actually had worsened by the end of the chemoradiotherapy. CONCLUSIONS: Positive and negative predictive values, in particular for partial response and stable disease, of clinical evaluation of the response to chemoradiotherapy were not high enough to consider clinical evaluation accurate enough to make treatment decisions.

Adult↗
PubMed1994

Pilot study of preoperative chemotherapy with cisplatin, vinblastine, and dacarbazine in patients with local-regional recurrence of melanoma.

BACKGROUND: Because the prognosis of patients with local-regional recurrence of melanoma treated with surgery alone usually is poor, the authors conducted a study designed to determine the efficacy of preoperative chemotherapy using cisplatin, vinblastine, and dacarbazine (CVD) in this patient population. METHODS: Eligibility included biopsy-proven, measurable, and potentially resectable local-regional disease in the form of lymph node metastases, satellite/in-transit metastases and/or local recurrence. CVD consisted of cisplatin, 20 mg/m2 intravenously (IV) on days 2-5; vinblastine, 1.6 mg/m2 IV on days 1-5; and dacarbazine, 800 mg/m2 IV on day 1 only, repeated every 3 weeks. Patients usually received two to three courses of CVD and then underwent surgery. Postoperatively, patients who responded continued CVD for a maximum of 8 courses; nonresponders received no further therapy. RESULTS: Of 52 consecutive patients (40 with lymph node involvement and 12 with skin metastases), 5 (10%) achieved a pathologic complete response and 20 (38%) achieved a partial response, for an overall response rate of 48% (95% confidence interval, 34-62). Of the five patients who achieved a pathologic complete response, three had attained a clinical complete response and one a partial response, and one had stable disease after initial chemotherapy. At a median follow-up of 54 months (range, 32-69 months), 38% of the patients remained disease free. CONCLUSION: Preoperative chemotherapy with CVD has significant activity in local-regional recurrences of melanoma, resulting in pathologic complete response in 10% of the patients. Because its impact on survival remains unclear, this treatment strategy should currently remain investigational. Preoperative chemotherapy, however, could be offered to certain patients with bulky, borderline resectable, regional disease for whom cytoreduction may make surgery easier or less mutilating.

Adult↗
PubMed2004

Relationship between time interval from primary surgery to the start of taxane- plus platinum-based chemotherapy and clinical outcome of patients with advanced epithelial ovarian cancer: results of a multicenter retrospective Italian study.

PURPOSE: To assess whether the interval from primary surgery to the start of taxane- plus platinum-based chemotherapy has any impact on the clinical outcome of advanced ovarian cancer patients. PATIENTS AND METHODS: The study was conducted on 313 patients who underwent surgery followed by taxane- plus platinum-based chemotherapy. The median follow-up of survivors was 30.7 months (range, 6 to 109 months). RESULTS: The 25%, 50%, and 75% quantiles of intervals from surgery to the start of chemotherapy were 11, 21, and 31 days, respectively. After the sixth cycle, 102 patients achieved a pathologic complete response at second-look surgery and 98 obtained a clinical complete response but were not submitted to second-look surgery. Taking into consideration the best assessed response, a complete (either clinical or pathologic) response was found in 200 patients. Residual disease (< or = 1 v > 1 cm; P < .0001) and ascites (absent v present; P = .003) were independent predictive factors for achieving a complete response, whereas residual disease (P = .001) and stage (IIc to III v IV; P = .04) were independent prognostic variables for survival. Conversely, statistical analyses failed to detect significant differences in complete response rates and survival among patients with an interval from surgery to chemotherapy shorter than 11 days, 12 to 21 days, 22 to 31 days, and longer than 31 days. CONCLUSION: The interval from surgery to the start of taxane- plus platinum-based chemotherapy seems to have neither a predictive value for response to treatment nor a prognostic relevance for survival of advanced ovarian cancer patients.

Adult↗
PubMedDate not supplied

Thiotepa in combination with cisplatin for primary epithelial ovarian cancer: a phase II study.

The objectives of this phase II protocol were: 1) to determine the clinical activity of thiotepa combined with cisplatin in suboptimally debulked advanced epithelial ovarian carcinoma as first-line chemotherapy, 2) to determine by surgery the response after 6 courses of chemotherapy, and 3) to identify the regimen's qualitative and quantitative toxicities. Patients with FIGO stage IIIC or IV epithelial ovarian cancer were eligible to receive cisplatin (50 mg/m2) followed by thiotepa (40 mg/m2) on an every 4-week schedule. Patients showing no evidence of disease after six cycles of chemotherapy underwent surgical reassessment. Thirty-one patients were evaluable for toxicity and response. Myelosuppression was the major toxicity and hematologic toxicities prompted all dose reductions. No growth factor support was given in this trial. Thirty-nine percent of patients (12/31) had a clinical complete response. Of these, 16% (5/31) had complete pathologic response and 19% (6/31) had partial pathologic response. One long-term survivor declined reassessment laparotomy. Including the 16% of patients with a partial response, the overall response rate was 55% (17/31). Five patients are currently alive 8 years after enrollment. Median survival was 16.8 months for all patients, 21.5 months for patients with partial response, and 60.8 months for patients with complete pathologic response. A normalization or >50% decrease in CA125 level occurred in 93% of patients. This study indicates that first-line treatment with thiotepa and cisplatin produces significant long-term responses when tumors are sensitive. Such treatment is a reasonable option when paclitaxel is not available.

Adult↗