Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical outcome, toxicity and organ/function preservation.

The purpose of the study was to assess response rate, clinical outcome, organ/function preservation and toxicity in head and neck cancer patients treated with induction chemotherapy followed by concomitant chemoradiotherapy and, when necessary, limited surgery. The study design was a phase II non-randomized trial in hospitalized patients setting. The treatment plan consisted of 3 cycles of induction chemotherapy with cisplatin, fluorouracil (5-FU), leucovorin and interferon alpha2b (PFL-IFN) followed by 7 cycles of 5-FU, hydroxyurea and concomitant radiation for 5 days (FHX) for a total radiation dose of 70 Gy. Surgical resection was performed, when necessary, with the intent to spare organ/function. Seventeen patients were treated at one institution. Three patients had stage III and 14 patients stage IV disease. Twelve patients were analyzed for response to PFL-IFN: 2/12 (16.7%) patients achieved a CR and 10/12 (83.3%) achieved a PR for an ORR of 100%. FHX was administered on protocol to 10 patients: 4 patients (40%) had CR, 3 (30%) had PR >/=70% for an ORR of 70%, 1 patient (10%) had SD and 2 patients (20%) had PD. As for local therapy, of the 8 eligible patients who completed chemoradiotherapy, the 3 patients with CR were submitted to random biopsies, results of which were histologically negative, 3 patients with PR >/=70% underwent conservative organ-preserving surgery, and 1 patient with PR >70% refused surgery, whereas the patient with SD underwent salvage surgery, preserving voice. Thus, organ preservation was achieved in all 8 patients at the completion of all therapy: 4 patients had no surgical procedure and 4 patients only conservative surgery. Overall, after completion of all therapy, 5/8 (62.5%) patients were rendered disease-free. The median overall survival time was 23 months, the median duration of response was 6 months and the median time to progression was 9 months. Both induction chemotherapy and concomitant chemoradiotherapy resulted in significant toxicity, which consisted mainly of mucositis and thrombocytopenia. In conclusion, PFL-IFN was very active, producing high ORRs and, followed by FHX, resulted in high overall survival rates permitting an optimal organ preservation, at the cost of a severe toxicity.

Phase II study of induction chemotherapy followed by concomitant chemoradiotherapy in advanced head and neck cancer: clinical response and organ/function preservation.

We planned to conduct a trial of induction chemotherapy followed by concomitant chemoradiotherapy with the goal of organ-function preservation in advanced head and neck cancer patients with the response rate and local control of disease as primary endpoints and the assessment of toxicity as secondary endpoint. The overall treatment plan consisted of 3 cycles, each q. 28 days, of induction chemotherapy with cisplatin, 5-FU, leucovorin and interferon alpha2b (PFL-IFN), followed by response evaluation and local therapy with concomitant chemoradiotherapy with 5-FU, hydroxyurea and concomitant radiotherapy (FHX). The evaluation of clinical response was performed during the 2nd week after the 3rd cycle of induction chemotherapy and FHX was initiated 28 days after the 3rd cycle of induction chemotherapy. Hydroxyurea was administered orally at doses of 1 g every 12 h x 11, 5-FU was administered on days 1 through 5 at 800 mg/m2/d for 5 days. Daily fraction of radiotherapy were administered at 2.0 Gy on days 1 through 5. FHX cycles were repeated every 14 days until completion of radiotherapy. Total radiotherapy doses consisted of 70 Gy. Seventeen patients (mean age 56.53 years, range 40-73, male/female 15/2, site: oral cavity 6, 35.29%; oropharynx 3, 17.6%; hypopharynx 3, 17.65%; larynx 2, 11.76%; paranasal sinuses 2, 11.76%; salivary glands 1, 5.88%; ECOG PS 0/1: 10/7, stage: III/IV 3/14) were enrolled from January 1998 to August 1998. All 17 patients initiated induction chemotherapy on this protocol. Twelve patients were analyzed for response (5 patients were not evaluable): 2/12 (16.7%) patients achieved a CR and 10/12 (83.3%) achieved a PR for an ORR of 100%. Concomitant chemoradiotherapy was administered on protocol to 10 patients: 4 patients (40%) had CR, 3 patients (30%) had PR >/=70% for an ORR of 70%, 1 patient (10%) had SD and 2 patients (20%) had PD. As for local therapy, according to treatment plan, of the 8 eligible patients who completed chemoradiotherapy, the 4 patients with CR were submitted to random biopsies, which resulted histologically negative, the 3 patients with PR >/=70% underwent conservative organ-preserving surgery, the patient with SD underwent salvage surgery, preserving voice. Thus, organ-preservation was achieved in all 8 patients at the completion of all therapy: 4 patients had no surgical procedure and 3 patients only conservative surgery. Overall, after completion of all therapy, 6/8 (75%) patients were rendered disease-free. Both induction chemotherapy and concomitant chemoradiotherapy resulted in significant toxicity, which consisted mainly of mucositis and thrombocytopenia. In conclusion, in the present study we have achieved a good clinical response and an optimal organ preservation, at the cost of a severe toxicity.

[Gastric leiomyoblastoma. A case report]. / Il leiomioblastoma gastrico. Presentazione di un caso.

The authors report a case of gastric leiomyoblastoma, a rare benign neoplasm that can sometimes undergo a malignant course. The main clinical an pathological issues are reviewed, in order to offer guidance as to the best suited surgical approach.

[Duodenal adenocarcinoma. A case report]. / Adenocarcinoma duodenale. Presentazione di un caso.

The duodenal carcinoma is a rare malignant neoplasm (1-6% of all the tumors of the digestive tract). In this paper the authors review the clinical and diagnostic approach to the disease and discuss both the palliative and curative surgical therapy.

[A case of small intestinal leiomyosarcoma]. / Un caso di leiomiosarcoma del tenue.

The Authors report a case of leiomyosarcoma of the small bowel, a rare neoplasm with severe limitations of pre-operative diagnosis. A discussion of the pathological staging, diagnosis and surgical therapy follows. At the moment, better diagnostic techniques and greater awareness of the disease notwithstanding, the prognosis remains severe due to the presence of local or distant metastases at laparotomy.

[A case of cystic lymphangioma of the liver]. / Su di un caso di linfangioma cistico del fegato.

Here is a case report about a cystic lymphangioma of the liver, a rare benign tumor, extremely difficult to diagnose with certainty in spite of the wide range of examinations today available. Surgical intervention is still the most important means to achieve the final diagnosis. The authors also provide a discussion about the pathogenesis and the clinical manifestation of the disease.

Response to neoplastic antigens in human oncology: assessment and results of LIF (leucocyte inhibitory factor) test in breast cancer patients.

The leucocyte inhibition factor (LIF) test, revealing the inhibition of leucocyte migration from capillary tubes, was studied with leucocytes from 47 patients with breast cancer, from 14 patients with benign breast tumors, and from 56 normal subjects. As antigens we used formalin-fixed tumor cells. The LIF assay was positive in 38/47 (80.8%) breast cancer patients, in 10/14 (71.4%) benign breast tumor patients, and in 13/56 (23.2%) normal subjects. The negative LIF assays were higher with leucocytes from patients with metastases than with those from patients with no metastases. We found no correlation between the LIF-test response and the histopathologic pattern of the tumors, type of treatment (almost always surgical), and remission or relapse state of our patients at the time of testing.