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PubMed2026

Response-adapted surgical de-escalation following neoadjuvant immunotherapy in resectable mucosal HNSCC A systematic review and meta-analysis.

INTRODUCTION: Recent encouraging outcomes with neoadjuvant immune checkpoint inhibitors (ICIs) in mucosal head and neck squamous cell carcinoma (HNSCC) have generated interest in surgical de-escalation. However, the oncologic safety of response-adapted surgery (RAS) and its ability to achieve survival outcomes comparable to baseline-planned surgery (BPS) remain uncertain. METHODS: A systematic search of the PubMed, EMBASE, Cochrane Library, and the Clinical Trials Registry for studies of neoadjuvant ICIs, with or without chemotherapy, in resectable mucosal HNSCC, that explicitly report surgical extent, between 2020-2025 was performed. Two independent reviewers extracted data following PRISMA guidelines. Main outcomes included major pathologic response (MPR), pathologic complete response (pCR), event-free survival (EFS), and overall survival (OS). Study-level proportions were pooled by random effects models. Heterogeneity was assessed by the I2 statistic. RESULTS: The comparative analysis consisted of 4 RAS studies (involving 202 patients) and 11 BPS studies (403 patients). The pooled overall EFS was 83.3% (76.9-88.2) for the former and 82% (75.2-87.2) for the latter (P=.751), and the respective pooled OS was 92.3% (87.5-95.3) and 91.4% (80.3-96.5) (P=.839). The pooled pCR rate was 41.7% (95% CI 5.4-48.4; I2=.0) for RAS and 19.8% (95%CI 13.3-29.6; I2=.62) for BPS (P=.001), while the MPR was not significantly different (59.6%, versus 48.5%, P=.245). RAS was associated with greater organ preservation and reduced need for mandibulectomy and free-flap reconstruction. CONCLUSIONS: RAS following neoadjuvant ICIs in mucosal HNSCC may enable surgical de-escalation with preserved oncologic outcomes and improved function in selected patients. Larger prospective studies are warranted.

Humans↗
PubMed1992

Dose-intensive induction therapy with cyclophosphamide, cisplatin, and consolidative abdominal radiation in advanced-stage epithelial ovarian cancer.

PURPOSE: The primary goal of this trial was to evaluate the clinical activity of a high-dose cisplatin-based induction regimen for women with advanced-stage ovarian cancer. A secondary goal was to assess the use of whole-abdominal radiation as consolidative therapy in the subset of women left with less than 5 mm residual disease after completion of chemotherapy. PATIENTS AND METHODS: Fifty consecutive patients with newly diagnosed, advanced-stage ovarian cancer received cisplatin 40 mg/m2/d and cyclophosphamide 200 mg/m2/d intravenously (IV) for 5 days, every 4 to 6 weeks. After three to four cycles of chemotherapy, patients who still had residual disease less than 5 mm in greatest diameter at second-look surgery were given whole-abdominal radiotherapy. RESULTS: The overall response rate in 49 patients assessable for response was 61.3% (24.5% pathologic complete responses [pCRs], 32.7% pathologic partial responses [pPRs], and 4.1% clinical partial responses [cPRs]). Median survival for all patients was 23.4 months, and actuarial 4-year survival was 33.7% (95% confidence interval [CI], 21.8% to 48.1%). Multivariate analysis showed stage III and serous histology as independent favorable prognostic factors for survival. Median survival for stage III patients was 36.5 months, with an actuarial 4-year survival of 41.6% (95% CI, 25.5% to 59.6%). Median survival for stage IV patients was 12.0 months, with actuarial 4-year survival of 22.9% (95% CI, 9.5% to 45.5%). The major acute toxicities encountered were myelosuppression and peripheral neuropathy. Patients who received consolidative radiotherapy were at increased risk of developing late-onset enteropathy. CONCLUSIONS: This regimen is active against advanced-stage ovarian cancer, but the associated toxicity is severe. Consolidative whole-abdominal radiation did not appear to prolong survival in the subset of women left with less than 5 mm residual disease after chemotherapy.

Adolescent↗
PubMed1996

Feasibility, toxicity, and preliminary results of weekly loco-regional hyperthermia and cisplatin in patients with previously irradiated recurrent cervical carcinoma or locally advanced bladder cancer.

PURPOSE: The biological rationale for combining locoregional hyperthermia (HT) with cisplatin (CDDP) is the potentiating effect of HT on CDDP uptake and cytotoxicity. Feasibility, toxicity, and preliminary results of a clinical trial of weekly loco-regional HT in combination with cisplatin are described in this article. METHODS AND MATERIALS: Patients with previously irradiated unresectable local recurrent cervical carcinoma or locally advanced bladder carcinoma were treated with weekly cycles of locoregional HT (70 MHz four antenna phased array system) for 1 h and CDDP 50 mg/m(2) IV for a maximum of 12 courses. RESULTS: Fourteen patients, 10 patients with recurrent cervical carcinoma and 4 with locally advanced bladder carcinoma, were entered in this study. A total of 100 cycles were given. Overall toxicity was acceptable; Grade 3 (WHO) toxicity (gastrointestinal, hematological, and neurotoxicity) was observed in 5 out of 14 patients. No Grade 4 toxicity was seen. Subcutaneously fatty necrosis due to HT occurred in 11% of the cycles, while two patients developed skin burns. Two out of 10 patients with recurrent cervical carcinoma were not evaluable for response. Four out of eight evaluable cervical carcinoma patients responded (two pathologic complete responses, one pathologic confirmed partial response, one partial response): response rate 50% (95% confidence interval 15.7-84.3%). Salvage surgery became possible in three out of four responding patients, whose tumors were previously considered unresectable. Two out of the four evaluable patients with locally advanced bladder carcinoma responded (two partial responses). CONCLUSIONS: Weekly loco-regional HT and CDDP 50 mg/m(2)/week for a maximum of 12 courses is feasible with an acceptable toxicity, which seems not to be enhanced by the addition of loco-regional HT. The encouraging preliminary results of this treatment schedule warrant further study, especially in patients with previously irradiated recurrent cervical carcinomas.

Adult↗
PubMed1992

The effect of systemic therapy on local-regional control in locally advanced breast cancer.

One hundred and seven patients with locally advanced breast cancer were prospectively referred for multimodality treatment on protocol using chemohormonal therapy to maximal response followed by local treatment and maintenance therapy. Forty-eight patients (45%) were diagnosed with Stage IIIA disease, 46 (43%) with Stage IIIB inflammatory cancer, and 13 (12%) with Stage IIIB non-inflammatory disease. Induction therapy consisted of cyclophosphamide, doxorubicin, methotrexate, and 5-fluorouracil with hormonal synchronization using tamoxifen and conjugated estrogens. Local treatment was determined by response to chemotherapy. Patients with a clinical parital response underwent mastectomy followed by local-regional radiotherapy while patients with a clinical complete response were biopsied for pathologic correlation. Those with residual disease received mastectomy followed by radiotherapy while those with a pathologic complete response received radiation only to the intact breast and regional nodes. With a median follow-up of 64 months, patients with IIIA disease had a significantly lower local-regional failure rate compared to IIIB inflammatory patients, with the 5-year actuarial local-regional failure rate as only site of first failure 3% for IIIA disease versus 21% for IIIB inflammatory cancer (p = .02), and local-regional failure as any component of first failure 12% versus 36% (p = .01), respectively. When local-regional failure was analyzed by repeat biopsy, 5/31 (16%) patients with a pathologic complete response treated with radiation only developed a local-regional failure versus 2/53 (4%) with residual disease treated with mastectomy and postoperative radiotherapy. The 5-year actuarial local-regional failure rate as first site of failure was 23% for radiation only versus 5% for mastectomy and post-operative radiotherapy (p = .07). The response to chemotherapy did not reliably predict local-regional control. Both relapse-free survival and overall survival were significantly better for IIIA versus IIIB patients; stratification by repeat biopsy did not however, significantly affect either relapse-free or overall survival.

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↗
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↗
PubMed1989

The influence of cytoreductive surgery on progression-free interval and survival in epithelial ovarian cancer.

In 1980, Dr George E. Moore published an editorial in Surgery, Gynecology and Obstetrics entitled 'Debunking debulking'. He included advanced ovarian cancer in his personal list of 'faulty' debulking procedures. Some of hist statements have merit. He contends that overly aggressive procedures that leave microscopic tumour cells that will soon grow and kill the patient are unindicated. He further points out that one cubic centimetre of tumour will contain approximately a billion cells. However, there are factors in ovarian cancer that should cause one to take exception to Dr Moore's statement. First, there is good evidence that the use of cisplatin-based multidrug chemotherapy may eradicate microscopic tumour deposits in a significant number of patients. Secondly, even multiple aggregates of tumour with a billion or more cancer cells can be eradicated in some cases, and in others can be reduced sufficiently to allow significant palliation. In evaluating the information which has been reviewed in this discussion of cytoreductive surgery for advanced ovarian cancer, it is apparent that cytoreductive surgery is not only indicated, but mandated in many facets of the management of ovarian cancer. The following principles seem to be supported by the existing literature: 1. Current diagnostic techniques do not enable us to diagnose ovarian cancer while still confined to the ovary. Therefore, in the immediate future we will still encounter a large number of patients with advanced disease. 2. The number of complete clinical responses and the number of complete pathological responses (negative second-look surgical reassessments) are greatest in those patients who begin adjunctive therapy with minimal residual disease. 3. Median duration of survival is longer, and long-term survival more likely, in those patients giving complete clinical or complete pathological responses. 4. Some patients appear to benefit from secondary cytoreductive surgery. However, at the present time, evidence of benefit from secondary cytoreductive surgery appears to be limited to those patients who have responded to adjunctive therapy and are found to have residual disease at surgical reassessment. There is no good evidence to support secondary cytoreductive surgery as an 'interval' procedure or its use in patients with progression on primary adjunctive therapy. This development of better chemotherapy regimens, such as cisplatin-based chemotherapy, has resulted in a greater need for effective primary cytoreductive surgery as it is apparent that, on utilizing these new regimens, better results are obtained in patients with minimal residual disease.(ABSTRACT TRUNCATED AT 400 WORDS)

Carcinoma↗
PubMed1989

High-dose platinum consisting of combined carboplatin and cisplatin in previously untreated ovarian cancer patients with residual disease.

A phase II trial of carboplatin, 300 mg/m2 day 1, and cisplatin, 50 mg/m2 days 2 and 3 every 4 weeks for six cycles, was performed in 42 previously untreated patients with residual disease after primary laparotomy. Overall, 79% of patients had primary residual tumor larger than 2 cm. The overall pathologic response rate (pathologic complete response [PCR] plus partial response [PPR]) in 37 evaluable patients was 62%, and in PCRs was 22%. Of the responding patients, 78% had primary residual tumor larger than 2 cm. The toxicity was cumulative but manageable, with thrombocytopenia being the main reason for dose reduction. Dose-limiting nephrotoxicity and neurotoxicity occurred in 22% and 7% of the patients, respectively. Combined high-dose platinum as a "single agent" appears to be as active as combination chemotherapy containing cisplatin, and the treatment is feasible. Further clinical trials of this combination alone or combined with other drugs are warranted.

Adult↗
PubMed1990

Combined high-dose carboplatin and cisplatin, and ifosfamide in previously untreated ovarian cancer patients with residual disease.

Carboplatin 200 mg/m2 day 1, cisplatin 50 mg/m2 days 2 and 3, ifosfamide 1,500 mg/m2 days 1 to 3, and mesna 900 mg/m2 days 1 to 3 every 4 weeks for six cycles were given to 37 previously untreated ovarian cancer patients with residual disease after the primary laparotomy. The median observation time was 17+ months (range, 9+ to 24+ months). Of all the patients, 81% had primary residual disease larger than 2 cm. The overall pathologic response rate (pathologic complete response [PCR] plus partial response [PPR]) in 36 assessable patients was 58%, PCR was 42%. Of the PCR patients, 53% had primary residual tumor larger than 5 cm. The substantial hematologic toxicity was manageable, but also the main reason for dose modifications. During treatment, 92% and 100% of the patients developed WBC and platelet nadir values corresponding to World Health Organization (WHO) grades 3 to 4. Dose-limiting encephalopathy, nephro- and neurotoxicity each occurred in 6% of the patients. The high PCR rate warrants further investigations of combined high-dose platinum and ifosfamide.

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↗
PubMed1994

Systemic chemotherapy for muscle invasive bladder cancer.

A total of 60 patients with muscle invasive transitional cell carcinoma of the bladder were entered into the nonrandomized study. The 1st group consisted of 30 patients treated by M-VAC neo-adjuvant chemotherapy followed by radical cystectomy when a residual tumor had been detected by biopsy made after the treatment. The overall clinical response was 70%. Fifteen (50%) out of 30 patients achieved clinical complete response (cCR). Objective pathologic response was attained in 6 (66.7%) of 9 evaluable patients who underwent radical cystectomy, pathologic complete response (pCR) was observed in two (22.2%) patients. Ten (33.3%) patients are still alive at a median follow-up of 22+ months. There were three (10%) drug-related deaths. The 2nd group consisted of 30 patients treated by CMV (with carboplatin) neo-adjuvant chemotherapy followed by radical pathologic response was attained in 9 (47.4%) of 19 evaluable patients, with pCR in 6 (31.6%) patients. Twenty four (80%) patients are still alive at a median follow-up of 13+ months. There was one (3.3%) drug-related death. The authors recommend immediate radical cystectomy following neo-adjuvant chemotherapy in all patients if their total status it allows.

Adult↗
PubMed1990

Prognostic factors in stage IV ovarian carcinoma treated with platinum-based regimens.

Eight factors were analyzed for prognostic significance in univariate analyses in a series of 76 women with stage IV ovarian carcinoma treated with combination chemotherapies including cisplatin or carboplatin. The clinical objective and pathologic complete response rates were 51.2% and 27.3%, respectively. Median overall survival and progression-free survival were 15 and 7 months, respectively. No variables reached statistical significance. Trends toward better survival were noted for grades 1 and 2 for the adriamycin-containing regimen. Using progression-free survival as an end point, significant prognostic factors included complete clinical or pathologic response. Our data confirm that the standard approach is unlikely to modify the clinical outcome of stage IV ovarian cancer. New treatment modalities including high-dose-intensity regimens and neo-adjuvant chemotherapy delivered before surgery could improve clinical results. Moreover, biologic characterization of ovarian tumors may provide information to design specifically targeted treatment.

Adult↗
PubMed1994

Phase II trial of intraperitoneal carboplatin in ovarian carcinoma patients with macroscopic residual disease at second-look laparotomy. A multicentre study of the French Fédération Nationale des Centres de Lutte Contre le Cancer.

BACKGROUND: Because of its antitumour activity and its pharmacological advantage when administered by the intraperitoneal route, carboplatin was studied in a phase II multicentric trial. The aim of the study was to determine the response rate and the toxicity of carboplatin administered intraperitoneally and to determine if pathological complete response could be attained in women with macroscopic residual ovarian cancer at second-look laparotomy after intravenous cisplatin chemotherapy. PATIENTS AND METHODS: Twenty-nine patients with macroscopical residual disease after intravenous cisplatin-based chemotherapy at second-look laparotomy, were treated at that time with 300 mg/m2 of carboplatin administered in the abdominal cavity every four weeks for six cycles. In instances of negative findings at physical and CT scan examination, laparotomy evaluation was performed and the catheter was removed. The dose of carboplatin was increased or decreased according to hematological toxicity. RESULTS: Efficacy is evaluable in 25 pts: 2 pts had pathological complete responses and 1 pt had microscopic disease (12% response rate of evaluable patients). Toxicity is evaluable for 135 cycles in 29 patients. No grade 4 hematological toxicity was observed, 2 pts had grade 3 leukopenia and 3 pts had grade 3 thrombocytopenia; grade 3 vomiting was observed in 11% of cycles. No peritoneal complication was observed; catheter dysfunction occurred after the first cycle in one patient who refused a surgical procedure to remove the catheter and to pursue treatment. CONCLUSION: Intraperitoneal carboplatin demonstrates efficacy in patients with macroscopical residual disease at second-look laparotomy after first-line cisplatin chemotherapy. The recommended dose for further studies is 300 mg/m2 administered every 4 weeks. A low response rate does not favour a randomised study.

Adult↗
PubMed1992

Therapy of patients with metastatic breast cancer with 5-fluorouracil, leucovorin and carboplatin.

Thirty-four women with metastatic breast cancer were treated at the National Cancer Institute of the National Institutes of Health, with a regimen of leucovorin (L), 500 mg/m2 i.v. over 30 min, followed in 1 h by 5-fluorouracil (5-FU), 375 mg/m2 i.v. bolus on days 1-5, and carboplatin (CBDCA), 50-100 mg/m2 i.v. bolus on days 2-4, every 28 days. All patients had received previous combination chemotherapy with at least one regimen (29 patients with 5-FU-containing regimens). CBDCA, 100 mg/m2 on days 2-4, resulted in grade 4 neutropenia in 10 out of 11 patients associated with sepsis in all 10 patients. CBDCA, 75 mg/m2 (seven patients) and 50 mg/m2 (15 patients), resulted in grade 4 neutropenia in six and eight patients, and neutropenic sepsis in five and two cases, respectively. Grade 4 thrombocytopenia occurred in 10, five and two patients receiving 100, 75 and 50 mg/m2 of CBDCA, respectively. Other toxicities included grade 3/4 mucositis in 18 patients and grade 3/4 diarrhea in 10 patients. Twenty nine patients were evaluable for response, with one pathologic complete response (3%), two partial responses (6%), 18 stable disease (53%) and eight (24%) progressive disease. Sites of response included bone, viscera and soft tissue. The median time from entry on study to progression, for responders, was 15 months. When platinum-DNA adduct formation in peripheral white blood cells was analyzed in 27 patients at 24 h after drug administration, a significant correlation between adduct level and CBDCA cumulative dose was found.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Alpha 2b interferon (IFN) by intraperitoneal administration via temporary catheter in ovarian cancer. Preliminary data.

Thirty-nine patients with epithelial ovarian cancer admitted to the Division of Medical Oncology of the Medical School II of Naples were given 159 courses of alpha 2b interferon (30 Mil./sqm IU) intraperitoneally from October 1986 to November 1989. IFN was generally administered every three weeks, but six patients received the drug weekly at the same dose, for an additional period. In 15 patients IFN was added to standard systemic chemotherapy as first line treatment; the remaining patients, all pretreated (22 with minimal and 2 with no residual disease), received an intraperitoneal multidrug treatment combining IFN, cisplatin and mitoxantrone. Peritoneal access was achieved through a temporarily implanted 18 gauge catheter and the drug was instilled in a large fluid volume (2,000 ml) to ensure wide spread and uniform distribution. IFN was well tolerated: only one patient had to discontinue treatment because of severe fatigue. No major complication related to catheter implantation or function occurred. 3/15 untreated and 11/20 pretreated patients, evaluable for response, achieved a pathological complete response (pCR). In view of IFN's lack of significant toxicity and the safety and tolerability of a temporary small gauge catheter for peritoneal access, intraperitoneal chemotherapy including IFN should be useful in ovarian cancer patients with minimal or absent disease after first-line systemic treatment.

Adult↗
PubMed1987

The treatment of advanced stage ovarian carcinoma with a combination of chemotherapy, radiotherapy, and radiosensitizer: report of a pilot study from the National Cancer Institute.

Twenty-eight patients with Stage III or IV ovarian carcinoma were treated with combined chemotherapy-radiotherapy employing a unique protocol. Four cycles of cyclophosphamide and hexamethylmelamine alternated with four cycles of concurrent cisplatin, whole abdominal radiotherapy, and intraperitoneal misonidazole. The entire treatment program lasted six months. Clinical complete responses were seen in 50% of the patients with an overall response rate of 61%. Pathologic complete response (PCR) confirmed at second look surgery occurred in 18% of the group (5 patients). Median survival of the entire group was 15.2 months with all PCR's alive NED. This outcome was no different than our previous experience with combination chemotherapy alone. Toxicities seen included leukopenia, thrombocytopenia, nausea, vomiting, and weight loss. However, these side effects were manageable. Two non-tumor deaths occurred. This study demonstrates the feasibility of combining drug and radiation therapy concurrently in the treatment of ovarian cancer; further research is needed to explore different sequencing and dose levels that could improve the outcome.

Adult↗
PubMed1995

Feasibility of five courses of pre-operative chemotherapy in patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction.

The purpose of this study was to examine the feasibility of administering all chemotherapy pre-operatively to patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. 32 patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction were studied in a stepwise fashion in which combination chemotherapy with cisplatin, high-dose arabinoside and 5-fluorouracil was administered. In the first part, 15 patients were to receive three chemotherapy courses pre-operatively and two chemotherapy courses postoperatively. In the second part, the next 15 patients were to receive all five chemotherapy courses pre-operatively, provided there was an objective response after three courses. Endoscopic ultrasonography was also performed, when feasible, prior to chemotherapy and surgery, and in some patients sequentially between chemotherapy courses. All of the 14 assessable patients in the first group tolerated all three courses of pre-operative chemotherapy, and 86% of patients in this group completed all protocol chemotherapy. In the second group, 9 of 18 (50%) assessable patients tolerated all five courses of preoperative chemotherapy, and 100% of patients in this group received all protocol chemotherapy. The median number of chemotherapy courses for the entire group (32 patients) was five (range one to five). Forty-one per cent (13/32) of patients had a major response to chemotherapy. Sixty-nine per cent (or 76% of 29 patients taken to surgery) had a curative resection. One patient had a pathological complete response. The median survival time of 32 patients was 17 months (range 2-36+ months). 14 patients (37%) remain alive at a median follow-up time of 26+ months. There was a correlation between endoscopic ultrasonographic tumour and nodal stage and pathological tumour and nodal stages in 16 patients. The tumour stage correlation was higher (75%) than the nodal stage correlation (62%). Our data suggest that it is feasible to administer five courses of cisplatin-based chemotherapy to patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. More effective chemotherapy regimens that might result in higher pathological complete response rates and acceptable toxic effects are needed.

Adenocarcinoma↗