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PubMed2000

Neoadjuvant therapy of squamous cell carcinoma of the esophagus.

Because of the high risk of recurrence following surgery for squamous cell carcinomas of the esophagus, treatment involving both systemic therapy and a localized approach [either surgery alone or chemo/radiation and surgery] have been extensively studied. Pilot trials have demonstrated safety for the use of chemotherapy followed by operation, or for chemotherapy plus standard radiation plus surgery. Larger scale phase III trials, in which either of these two strategies is employed, have now been reported. For chemotherapy followed by surgery, conflicting results have recently been noted. A US intergroup trial showed no significant outcome for all patients treated. A smaller European study, also using a cisplatin-based regimen, had a positive result. Similarly, for chemoradiation followed by operation, two recent random assignment studies failed to demonstrate a significant difference in outcome. However, recently newer chemotherapy agents have been identified which hold promise for more effective therapy. These include paclitaxel and irinotecan. Phase II trials, using these agents prior to surgery, are underway or have been completed, and phase III studies are in the advanced planning stage. Until these trials have demonstrated superiority, surgery alone or chemoradiation without surgery remain the standard of care, for patients with esophageal cancer.

Carcinoma, Squamous Cell↗
PubMed1989

Neoadjuvant therapy of squamous cell carcinoma of the esophagus: role of resection and benefit in partial responders.

Twenty-eight patients were treated between 1981 and 1987 with a combination of radiation therapy and two courses of 5-fluorouracil and cisplatin followed by esophageal resection. Sixteen patients (57%) underwent resection. Operative mortality was 6% (1 of 16), and the 15 operative survivors have been followed for more than 23 months. Complete pathological response was achieved in 8 of the 15 patients, and 10 patients (66%) are alive with no evidence of disease; 4 patients (27%) have survived with no evidence of disease for more than 5 years. Four partial responders are alive, and 3 are alive with no evidence of disease for more than 5 years. An aggressive approach with a low mortality has demonstrated survival benefit to complete responders and, contrary to findings of previous reports, has established a role for surgical resection and survival benefit in patients with partial response, with 3 of 7 (47%) patients surviving more than 5 years.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

Neoadjuvant therapy for advanced squamous cell carcinoma of the cervix: cisplatin followed by radiation therapy--a pilot study of the Gynecologic Oncology Group.

Eleven patients with untreated advanced squamous cell carcinoma of the cervix (FIGO Stage IIIB and IVA, or positive paraaortic nodes) were treated with cisplatin 50 mg/m2 every 3 weeks for six courses prior to irradiation therapy (RT). Six patients completed six courses of cisplatin prior to RT with one complete and two partial responses (PR). Five other patients did not complete cisplatin therapy; two progressed after two and three courses, one had a PR after three courses and refused further therapy, one refused treatment after two courses and one elected to begin RT after one course. Two patients had reversible nephrotoxicity. No other major toxicity was noted. Six patients had stem cell assay prior to treatment and assay results were predictive of cisplatin response in five. Only one patient remains alive at 44+ months. Cisplatin chemotherapy prior to irradiation therapy is feasible and without substantial toxicity but is unlikely to be of benefit in patients with advanced cervical cancer.

Adult↗
PubMed1988

A phase II trial of mitomycin, vincristine, bleomycin, and cisplatin (MOBP) as neoadjuvant therapy in high-risk cervical carcinoma.

Twenty patients with locally advanced or metastatic cervical carcinoma were treated with mitomycin, vincristine, bleomycin, and cisplatin (MOBP), prior to radiotherapy (RT) of curative intent. Five patients had stage I disease, 2 stage II, 10 stage III, and 3 stage IV. All but one patient with stage I and II disease had nodal metastases. Patients received two courses of MOBP prior to and cisplatin q 3 weeks during RT. Response rates after completion of MOBP and prior to RT were as follows: 3/18 (16.6%) patients had a complete response (CR), 10/18 (55.5%) had a partial response (PR), 3/18 (16.6%) had improvement, and 2/18 (11.1%) had no response (NR). Five patients developed radiation complications. Of 7 patients with stage I and II disease, 6 (86%) currently have no evidence of disease (NED) (median 27 months). Of 13 patients with advanced disease, 3 (23%) are NED (median 17 months), 8 (61.5%) have expired, and 2 (15.4%) are alive with disease. MOBP is associated with significant response rates in the untreated patient but has not improved survival in patients with advanced disease. Patients with early disease and positive nodes may benefit from this regimen.

Adenocarcinoma↗
PubMed2004

Pathological T0 prostate cancer without neoadjuvant therapy: clinical presentation and follow-up.

INTRODUCTION AND OBJECTIVES: Radical prostatectomy is a standard therapy for patients with prostate cancer diagnosed by prostatic needle biopsy, prostate cytology, transurethral resection of the prostate or prostatectomy. In a small group of patients no tumour can be found in the radical prostatectomy specimen. These cases are classified as stage pT0. The aim of this study was to evaluate the clinical presentation of this entity and their prognosis. MATERIAL AND METHODS: In a nation-wide database the clinical data of 3609 patients with prostate cancer were collected. 28 patients (0.8%) were staged as pT0 in the radical prostatectomy specimen. The data included age, prostate specific antigen (PSA), and pathological report at diagnosis, histology of the radical prostatectomy specimen and follow-up data. RESULTS: The diagnosis was made by TURP (transurethral resection of the prostate) in 15, prostatectomy in 2, needle biopsy in 11, and cytology in 2 patients. For patients who underwent TURP or prostatectomy the preoperative staging was T1a in 10 and T1b in 5 cases. 12 patients diagnosed by biopsy or cytology were classified T2a and one patient after biopsy as T2b. 9 patients had a GI- and 19 a GII-tumour, GIII-pattern was not represented. The mean age at diagnosis was 64.7 years (range 53-79 years). The PSA at the time of diagnosis was <4ng/ml in 8 cases; 4-10ng/ml in 16 cases and >10ng/ml in 4 patients. One patient presented with a micrometastasis in a single lymph node. Median follow-up was 62 months (19-150). All patients had undetectable PSA levels following surgery. No patient presented with clinical or biochemical progression. One patient died with no evidence of disease at 133 months after radical prostatectomy. CONCLUSIONS: None of the clinical parameters had a strong association with a pathologically proven T0 situation after radical prostatectomy in this setting. Interestingly no patient had a high-grade tumour. None of the patients classified as pT0 had a biochemical or clinical relapse during follow-up.

Adult↗
PubMed2000

Is MIB-1 proliferation index a predictor for response to neoadjuvant therapy in patients with esophageal cancer?

BACKGROUND: The overall survival rate for patients with an esophageal cancer remains poor. As a consequence, preoperative chemoradiation was introduced for patients with tumor stage T >1 M0 regardless of tumor histology or localization. However, factors predicting response to this therapy pretherapeutically are largely unknown. METHODS: Clinical results of preoperative chemoradiation were investigated. The rates of proliferation and apoptosis were determined in pretherapeutic tumor samples and correlated with tumor response and long-term survival after surgery. RESULTS: A complete tumor response due to chemoradiation (n = 42; cervically localized tumors excluded) was achieved in 11 patients (26%) after resection. Five-year survival rate was significantly improved in these patients compared with those who did not respond to chemoradiation (48% versus 5.5%; P = 0.003). Chemoradiation was performed without benefit in 43%. Perioperative hospital mortality rate was 14.3% in all patients. No correlation of apoptosis with response to chemoradiation or postoperative long-term survival was observed. However, there was a clear correlation between the proliferation rate as determined by MIB-1 immunohistology. Five-year survival rate of patients with a proliferation index (PI) >/=39% was 38% compared with 0% in tumors with a PI <39%. Tumors with a PI >/=39% responded to chemoradiation in 71.4%, but 100% of tumors with a PI <39% did not. Mean survival time of these patients was 33 months and 11 months, respectively (P = 0.015). CONCLUSIONS: The results indicate that the PI may be used for stratification of patients treatment prior surgery. However, these results need further validation in larger patient numbers in the search for factors indicating response pretherapeutically to preoperative chemoradiation in esophageal cancer.

Adenocarcinoma↗
PubMed1997

Intensity of neoadjuvant therapy in resectable non-small cell lung cancer.

Induction chemotherapy prior to definitive local treatment improves the survival of patients with Stage III non-small cell lung cancer. Several strategies to improve on the impact of 2 or 3 cycles of conventional induction chemotherapy are under study. Immediate concurrent chemoradiation followed by surgery has been evaluated extensively in the Phase II setting. This approach is now the subject of a Phase III trial in North America. Increasing the number of induction chemotherapy cycles or using high dose chemotherapy with autologous stem cell support are other strategies currently under evaluation. Understanding whether either of these approaches will improve survival for patients with Stage III NSCLC must await future Phase III trials.

Carcinoma, Non-Small-Cell Lung↗
PubMed1996

Assesssment of the effect of pretreatment with neoadjuvant therapy on primary breast cancer.

Patients with invasive cancer of the breast (T1-4, N0-2, M0) were assigned to pretreatment based on oestrogen receptor (ER) status; patients with ER-negative tumours received chemotherapy [mitozantrone, methotrexate and mitomycin C (MMM)] for 3 months, patients with ER-positive tumours underwent endocrine therapy [luteinising hormone releasing hormone (LHRH) agonist goserelin (leuprolide-premenopausal) or 4-hydroxyandrostenedione (formestane-post-menopausal)] for 3 months. Of the first 100 patients assessed at 3 months, 47 with ER-positive tumours had a 40.4% response (premenopausal 53.8%; post-menopausal 35%) and 53 with ER-negative tumours had a 60% response (premenopausal 57%; post-menopausal 63%). Patients with early breast cancer (T1/T2) had a complete clinical resolution in 41% (16/39) of cases after MMM and in 20% (7/35) of cases following endocrine therapy compared with 14% (2/14) advanced tumours (T3/T4) following MMM and (0/12) following endocrine therapy. However, in those patients achieving a complete clinical response, subsequent appropriate surgery showed that 16 of 19 patients (84%) had evidence of residual viable tumour on histological examination.

Adult↗
PubMed1999

Neoadjuvant therapy.

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Chemotherapy, Adjuvant↗
PubMed2000

Neoadjuvant therapy for organ preservation in head and neck cancer.

OBJECTIVES/HYPOTHESIS: We designed two sequential trials of induction chemotherapy followed by definitive radiation in patients with potentially resectable head and neck cancer to determine whether organ preservation is feasible without apparent compromise of survival Study Design Both trials were Phase II studies. METHODS: Two clinical trials were conducted sequentially at the University of Michigan. Fifty-two patients enrolled in the first study and were treated with a planned three cycles of carboplatin and 5-fluorouracil. Patients who achieved at least 50% reduction in the size of the primary tumor received definitive radiation therapy, to a dose of 6600 to 7380 cGy. Patients with minimal response or progression had immediate salvage surgery. Thirty-seven patients enrolled in the second trial, in which the chemotherapy consisted of carboplatin, 5-fluororuracil, and leukovorin. Responders were treated with accelerated radiation therapy, to a total dose of 7120 cGy delivered in 41 fractions over 5.5 weeks. RESULTS: Toxicity and response were similar in both trials; therefore, the results are reported first separately and then combined for all 89 patients. Tumor sites included: oropharynx, 55 patients; hypopharynx, 34 patients. Eighty-three percent of patients tolerated all three cycles of chemotherapy and toxicity was mild. Response to chemotherapy was: 48% complete response at the primary tumor site, and 34% partial response at the primary tumor site. Initial organ preservation at individual tumor sites was: oropharynx, 58%; hypopharynx, 59%. Median survival was 28 months, and survival at 3 and 5 years was 40% and 24%, respectively. CONCLUSIONS: These two regimens were well tolerated, and survival did not appear to be compromised by organ preservation treatment compared with historical controls. This approach warrants further investigation, particularly in those patients for whom surgery could be functionally debilitating.

Adult↗