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D Giannarelli

Publications and source records attributed to D Giannarelli.

At least 55 records · Page 3Linked to original sources
PubMed1999

Phase II study of epirubicin and vinorelbine with granulocyte colony-stimulating factor: a high-activity, dose-dense weekly regimen for advanced breast cancer.

BACKGROUND: This study was designed to explore the effectiveness and tolerability of a weekly regimen of epirubicin and vinorelbine plus granulocyte colony-stimulating factor (G-CSF). PATIENTS AND METHODS: Fifty-two patients with previously untreated advanced breast cancer were treated with epirubicin (25 mg/m2/week) and vinorelbine (25 mg/m2/week) with G-CSF support, for 24 consecutive weeks. RESULTS: The median number of courses per patient was 22 (range 10-24). The administered dose intensity was 23 mg/m2 for both epirubicin and vinorelbine. Ten complete responses (19%) and 30 partial responses (58%) were obtained, for an overall response rate of 77%. None of the patients progressed during treatment. The median response duration and time to progression were both 10 months. A total of 1065 courses were assessed for toxicity. Grade 3 neutropenia was the most common toxic manifestation, (39% of patients), without febrile neutropenia or neutropenic sepsis. Two patients had grade 3 cardiac toxicity, which regressed without sequelae. Median survival was 31 months, with a median follow-up of 24 months (range 9-40). CONCLUSIONS: Owing to its effectiveness and tolerability, the weekly regimen of epirubicin and vinorelbine plus G-CSF may represent an acceptable alternative for patients with untreated metastatic breast cancer. It could be tested in the adjuvant and neoadjuvant setting.

Adult↗
PubMed1999

Neo-adjuvant chemotherapy and bladder preservation in locally advanced transitional cell carcinoma of the bladder.

BACKGROUND: The possibility of bladder preservation as well as the utility of neo-adjuvant chemotherapy for invasive bladder cancer are controversial issues. The purpose of this study was the evaluation of neo-adjuvant M-VAC chemotherapy and bladder preservation in patients with locally advanced transitional cell carcinoma of the bladder. PATIENTS AND METHODS: Eighty-seven consecutive evaluable patients with T2-T4aNxM0 TCC of the bladder were treated with three cycles of neo-adjuvant M-VAC chemotherapy. After three cycles of M-VAC, 42 patients had TURB alone, 13 patients underwent partial cystectomy, and 32 patients were to undergo radical cystectomy. RESULTS: Forty (51%) patients were T0 at the TURB following M-VAC. Thirty (71%) patients who had chemotherapy and TURB alone are alive; at a median follow-up of 54+ months (8(+)-109+). Twenty-four (57%) have maintained an intact bladder. Of 13 responding patients with monofocal lesions who underwent partial cystectomy, 8 patients (62%) are alive with a functioning bladder, at a median follow-up of 80+ months (16-107+ months). At a follow-up of 32 months (7-121+ months), 20 (63%) patients in the radical cystectomy group are alive. In patients who had downstaging to T0 or superficial disease, median follow-up is 55 months (10-121+ months) and five-year survival is 71%. Patients who failed to respond (T2 or greater after chemotherapy), at a median follow-up of 24 months (7-103+ months), had five-year survival of only 29%. CONCLUSIONS: Bladder sparing in selected patients on the basis of response to neo-adjuvant chemotherapy is a feasible approach which must be confirmed in prospective randomized trials.

Adult↗
PubMed1999

Hyperthermic antiblastic perfusion with alpha tumor necrosis factor and doxorubicin for the treatment of soft tissue limb sarcoma in candidates for amputation: results of a phase I study.

To improve the therapeutic effectiveness of hyperthermic antiblastic perfusion (HAP), the association of recombinant tumor necrosis factor alpha (rTNF alpha), doxorubicin, and true hyperthermia (41 degrees C) was employed for the treatment of soft tissue limb sarcoma. A dose-escalation study according to Fibonacci's modified scheme was conducted, starting with a rTNF alpha dose of 0.5-3.3 mg. The doxorubicin doses (0.7 and 1.4 mg for the upper and lower limbs, respectively) and temperature level (41 degrees C) remained unchanged. Eighteen patients have been treated thus far: 9 males and 9 females of a mean age of 33 years (range: 24-71 years). The tumor was located in the upper limb in one patient and in the lower limbs in seventeen. Only 16 patients were evaluable, as 2 refused further treatment after the perfusion. In terms of local toxicity, a grade I limb reaction was observed in 3 patients, a grade II or III in 10 patients, and a grade IV in 5 patients, showing a strict correlation between the TNF dose and the grade of limb reaction. In fact, a grade III-IV limb reaction was observed in 66.6% of the patients treated with > 1 mg of rTNF alpha. The maximum tolerable dose in association with doxorubicin and true hyperthermia (41 degrees C) was 2.4 mg. Eleven patients showed a good pathological response (> 75%) and five patients showed a partial response (> 25%-< 75%). In no case was stable or progressive disease observed. The postperfusional tumor shrinkage permitted limb-sparing surgery in 75% of the patients, all of whom were candidates for amputation before HAP. No recurrences have been observed thus far. Two patients developed regional disease: one presented with a skip femur metastasis that disappeared after radiotherapy and systemic chemotherapy; the second developed regional node involvement, requiring a radical node dissection. Another patient had pulmonary metastases, 2 months after the HAP, which were resected. At a median follow-up of 12 months, all the patients are living without disease. The results of this phase I study suggest that the association of rTNF alpha, doxorubicin, and true HAP (41 degrees C) by regional perfusion is feasible and safe at a maximum tolerable rTNF alpha dose of 2.4 mg. However, because no correlation was found between the amount of rTNF alpha and the tumor response, 1 mg is recommended as the dose able to provide a high tumor necrosis rate and low local and systemic toxicity. This association appears to play an important role in the neoadjuvant treatment of soft tissue limb sarcoma.

Adult↗
PubMed1998

Radiation therapy in the management of symptomatic bone metastases: the effect of total dose and histology on pain relief and response duration.

PURPOSE: In order to better define variables and factors that may influence the pain response to radiation, and to look for a radiation regimen that can assure the highest percentage and the longest duration of pain relief, we performed a prospective, although not randomized, study on patients with bone metastases from various primary sites. METHODS AND MATERIALS: From December 1988 to March 1994, 205 patients with a total of 255 solitary or multiple bone metastases from several primary tumors were treated in our radiotherapy center with palliative intent. Irradiation fields were treated with three main fractionation schedules: (1) Conventional fractionation: 40-46 Gy/20-23 fractions in 5-5.5 weeks; (2) Short course: 30-36 Gy/10-12 fractions in 2-2.3 weeks; (3) Fast course: 8-28 Gy/1-4 consecutive fractions. Pain intensity was self-assessed by patients using a visual analogic scale graduated from 0 (no pain) to 10 (the strongest pain one can experience). Analgesic requirement was assessed by using a five-point scale, scoring both analgesic strength and frequency (0 = no drug or occasional nonopioids; 1 = Nonopioids once daily; 2 = Nonopioids more than once daily; 3 = Mild opioids (oral codeine, pentazocine, etc.), once daily; 4 = Mild opioids more than once daily; 5 = Strong opioids (morphine, meperidine, etc.). Complete pain relief meant the achievement of a score < or = 2 in the pain scale or 0 in the analgesic requirement scale. Partial pain relief indicated a score of 3 to 4 or of 1 to 2 on the former and latter scale, respectively. RESULTS: Total pain relief (complete + partial) was observed in 195 (76%) sites, in 158 of which (62%) a complete response was obtained. Metastases from NSC lung tumors appeared to be the least responsive among all primary tumors, with 46% complete pain relief in comparison to 65% and 83% complete relief in breast (p = 0.04) and in prostate metastases (p = 0.002), respectively. A significant difference in pain relief was detected among the several ranges of total dose delivered to the painful metastases, with 81%, 65%, and 46% complete relief rates in the 40-46 Gy, 30-36 Gy (p = 0.03), and 8-28 Gy (p = 0.0001) dose ranges respectively. A straight correlation between total dose and complete pain relief was confirmed by the curve calculated by the logistic model which shows that doses of 30 Gy or more are necessary to achieve complete pain relief in 70% or more of bone metastases. This correlation holds also for the duration of pain control, as shown by the actuarial analysis of time to pain progression. Multivariate analyses, with complete pain relief and time to pain progression as endpoints show a highly significant effect of radiation dose (p = 0.0007) and performance status (p = 0.003), with lower rates of complete pain relief and shorter time to pain progression observed after smaller radiation total doses or higher Eastern Cooperative Oncology Group (ECOG) scores. CONCLUSION: Although single-dose or short course irradiation is an attractive treatment in reducing the number of multiple visits to radiotherapy departments for patients with painful bone metastases, it is nevertheless clear that aggressive protracted treatments seem to offer significant advantages especially for patients in whom the expected life span is not short.

Analgesics↗
PubMed1998

Randomized prospective clinical trial of high-dose epirubicin and dexrazoxane in patients with advanced breast cancer and soft tissue sarcomas.

PURPOSE: We conducted a randomized trial to evaluate primarily the cardioprotective effect of dexrazoxane (DEX) in patients with advanced breast cancer and soft tissue sarcomas (STS) treated with high-dose epirubicin (EPI). We wished also to determine the value of radioimmunoscintigraphy (RIS) in the assessment of anthracycline cardiotoxicity. PATIENTS AND METHODS: Patients with breast cancer (n = 95) or STS (n = 34) received EPI 160 mg/m2 by intravenous (I.V.) bolus every 3 weeks with or without DEX 1,000 mg/m2 I.V. Cardiac monitoring included multigated radionuclide (MUGA) scans with determination of resting left ventricular ejection fraction (LVEF), and RIS with indium 111 antimyosin monoclonal antibodies. RESULTS: In either disease, antitumor response rates, time to progression, and survival did not significantly differ between the two arms. There was little difference in noncardiac toxicity for the two treatment groups. All methods of cardiac evaluation clearly documented the cardioprotective effect of DEX. Four patients developed congestive heart failure (CHF), all in the EPI arm. The decrease in LVEF from baseline was significantly greater in the control group. An abnormal antimyosin uptake was observed early in both arms and progressively increased during treatment. However, this increase was significantly higher in the EPI group (P = .004). CONCLUSION: DEX significantly protects against the development of cardiotoxicity when high single doses of EPI are used. Apparently, there was no evidence of an adverse impact of DEX on antitumor activity. Although RIS is a sensitive technique in detecting anthracycline cardiac damage, its specificity is low and it cannot be considered a primary test for guiding anthracycline treatment.

Adult↗
PubMed1998

Diagnostic and prognostic value of peritoneal immunocytology in gastric cancer.

PURPOSE: Among the clinical factors with a pivotal role in the prediction of outcome for patients with gastric cancer, intraperitoneal (i.p.) microscopic dissemination may represent an important cause of recurrences, even in the early stages of the disease. In this context, the cytologic examination of intraoperative peritoneal washings may be essential to identify metastatic free cells, although a number of false-negative cases may be encountered. PATIENTS AND METHODS: To determine whether immunocytochemical (ICC) methods that used a panel of three monoclonal antibodies (MoAbs), B72.3, AR3, and BD5, directed to gastric cancer-associated antigens can improve peritoneal cytology by providing more accurate prognostic indications, we immunocytochemically and morphologically evaluated 144 peritoneal washings sampled from patients surgically treated for gastric cancer. RESULTS: The ICC analysis allowed the identification of metastatic free peritoneal cells in 35% of the patients, with a 14% improvement over routine cytopathology (P < .0001). Furthermore, a 54-month survival analysis by Kaplan-Meier curves showed a statistically significant decrease in overall survival (OS) in patients with stages I through III disease with peritoneal microscopic disease detected morphologically and/or by ICC at the time of the primary surgery. CONCLUSION: Our data indicate that the use of a combination of selected MoAbs may allow the identification of cytologically false-negative cases that provide valuable prognostic information. This may be useful to stratify patients on more adequate therapeutic trials.

Adult↗
PubMed1997

Clinical significance of alpha(v)beta3 integrin and intercellular adhesion molecule-1 expression in cutaneous malignant melanoma lesions.

Several lines of experimental evidence in in vitro and animal model systems suggest that the integrin alpha(v)beta3 plays a role in the tumorigenicity of human melanoma cells and that the blocking of alpha(v)beta3 ligand binding can inhibit tumor progression. However, there is only scanty information about the role of alpha(v)beta3 in malignant melanoma in a clinical setting. Therefore, in the present study, we have analyzed the distribution in lesions of melanocyte origin and in normal tissues of the alpha(v) integrin subunit and of the alpha(v)beta3 complex and their association with histopathological and clinical parameters of malignant melanoma. We have used as probes the monoclonal antibodies (mAbs) TP36.1 and VF27.263.15, which we have shown with a combination of serological and immunochemical assays to be specific for the alpha(v) subunit and for the alpha(v)beta3 complex, respectively. In immunohistochemical assays, mAb TP36.1 stained both benign and malignant lesions of melanocyte origin. In contrast, the reactivity of mAb VF27.263.15 was restricted to malignant lesions. Both mAbs displayed differential reactivity with primary melanoma lesions of different histotypes because they stained about 50% of acral lentiginous melanoma and superficial spreading melanoma lesions, at least 80% of nodular melanoma lesions, and none of the uveal melanoma lesions tested. Both mAbs TP36.1 and VF27.263.15 stained about 60% of lymph node metastases and 80% of cutaneous metastases. Expression of the alpha(v)beta3 complex in melanocytic lesions resembles that of intercellular adhesion molecule-1 (ICAM-1) in several respects: (a) both are expressed in a significantly (P < 0.004) larger proportion of malignant than of benign lesions; (b) expression of both molecules in primary melanoma lesions is significantly (P < 0.05) associated with lesion thickness; and (c) expression of both molecules in primary lesions from patients with stage I melanoma is significantly (P < 0.05) associated with an increased probability of disease recurrence following surgical excision. alpha(v)beta3 and ICAM-1 in primary melanoma lesions complement each other in predicting the outcome of the disease, because the association with prognosis was enhanced when primary lesions were stained by both anti-alpha(v)beta3 mAb VF27.263.15 and anti-ICAM-1 mAb CL203.4 or by neither mAb. Because alpha(v)beta3 has been suggested as a potential target of immunotherapy, its distribution in normal tissues was investigated. alpha(v)beta3 expression is restricted because it was only detected in ductal epithelium of parotid glands, thyrocytes, basal glands of the stomach, colonic and rectal epithelium glomeruli, Bowman's capsules and proximal and distal tubules of kidneys, and endometrial epithelium. These findings suggest that renal function will be a critical clinical parameter to monitor in therapies of malignant diseases relying on systemic administration of anti-alpha(v)beta3 mAb.

Antibodies, Monoclonal↗
PubMed1997

Results of Bard BTA test in monitoring patients with a history of transitional cell cancer of the bladder.

OBJECTIVES: To evaluate the sensitivity and specificity of the Bard BTA test compared with bladder washing cytology in patients with a history of transitional cell bladder cancer undergoing routine follow-up cystoscopy. METHODS: During routine follow-up for transitional cell bladder cancer, 75 patients underwent cystoscopy, bladder washing cytology, and the Bard BTA test, a latex agglutination test that qualitatively detects basement membrane complexes in voided urine. From October 1994 to October 1995, a total of 104 Bard BTA test examinations were performed. The results of the Bard BTA test were compared with those attained with cystoscopy and bladder washing cytology. RESULTS: Cystoscopy found tumors in 13 cases. The Bard BTA test was diagnostic in 7 (54%) cases; it was more sensitive than bladder washing cytology, which was positive in only 3 (23%) cases. However, the specificity of the Bard BTA was lower (9% clinically unconfirmed positive tests) than that attained with cytology. In 2 patients (2%) in whom the cystoscopy was negative, the Bard BTA test was predictive for a positive cystoscopy 3 and 5 months later. CONCLUSIONS: The Bard BTA test is a noninvasive test that may be an important addition to cystoscopy and cytology in the routine surveillance of patients with a history of transitional cell cancer of the bladder.

Adult↗
PubMed1997

Medium-large polyps of the colon: a contribution for their clinical profile and a proper surveillance.

A retrospective analysis of polypoid lesions of the colon larger than 1 cm was performed with the aim to study their characteristics and a proper surveillance schedule. We reviewed all colon polypoid lesions larger than 1 cm found and treated during the period January 1984- December 1993 that were not considered cancer macroscopically. The records of 361 patients with 391 polyps are the object of this report. The polyps were divided into subgroups according to size: A) less than 20 mm, B) between 21 and 30 mm, and C) larger than 30 mm. Out of 391 polypoid lesions 373 were adenomas: 60% were found in males. The age group distribution showed no differences among the subgroups. The pedunculated type showed a decrease from 69.1% to 43.3% with the increasing of size: inverse figures were observed for sessile polyps. The lesions were mainly located in left colon. Synchronous adenomas were found in 25.4% patients, and metachronous and previous adenomas respectively in 24.8% and 5.2%: no significant difference was present in the subgroups. Synchronous malignancy in the colon was found in 2% of the patients. Histological characteristics demonstrated a decrease of tubular adenoma from 46.5% to 22.6% from subgroup A to C, while villous adenomas increased inversely from 6.6% to 15.1%. The presence of severe dysplasia ranged from 20.9% to 56.1% in subgroups A and C, respectively, and adenomas with invasive cancer showed a significant increase from the subgroup A to C, respectively from 4.3% to 10.5%. During an average 36-month follow-up we observed 2 metachronous colon cancers, surgically treated in Dukes stage B, 84 metachronous adenomas, all less than 10 mm and without malignant alterations. Our data confirm other literature reports regarding the profile of colon adenomas with an increasing risk of malignancy with the increase of size and the presence of villous structure. In our opinion the assessment of a "clean colon" status is important when an adenoma is found in the colon. The proper follow-up for adenomas must be tailored for any individual patient when risk factors such as size, villous structure, personal and family history of neoplastic lesions of the colon are present. The follow-up schedule, presently recommended for colon adenomas, must be flexible according to these parameters.

Adenoma↗
PubMed1995

Intrapatient comparison of single-agent epirubicin with or without lonidamine in metastatic breast cancer.

The aim of this study was to determine if lonidamine (LND) supplementation to single-agent epirubicin (EPI) could reverse anthracycline resistance in patients with metastatic breast cancer. 45 patients with metastatic breast cancer were treated with EPI 120 mg/m2 by intravenous (i.v.) bolus every 3 weeks. Patients who progressed were given the same chemotherapy regimen on day 4 in combination with oral LND, 150 mg on day 1, 300 mg on day 2 and 450 mg on days 3-5. Among the 40 evaluable patients, 6 complete responses (CR) and 14 partial responses (PR) were achieved with EPI treatment alone for an overall response rate of 50%. The median duration of response was 6.5 months. Among the 25 patients treated with EPI+LND, 5 PR (21% of 24 evaluable patients) were observed with a median duration of response of 7 months. The median survival in patients receiving both treatments was 20 months. The survival for all patients was 18 months. The survival of patients receiving LND was not significantly longer than for the other patients. Myelotoxicity was the most common side-effect followed by alopecia, nausea and vomiting, and stomatitis. LND-related toxic effects were mild-to-moderate epigastralgia and myalgia. Anthracycline-related toxicity was the same in the two treatment groups. This study indicates that LND may circumvent clinical resistance to EPI without altering the pattern or severity of the toxicity of this anthracycline. Continued investigation of the clinical modulation of EPI resistance by LND in breast cancer is warranted, hopefully in patients with known multidrug resistance status.

Adult↗
PubMed1995

Accelerated chemotherapy with high-dose epirubicin and cyclophosphamide plus r-met-HUG-CSF in locally advanced and metastatic breast cancer.

BACKGROUND: This study evaluated the toxicity of high-dose epirubicin and cyclophosphamide plus r-met-HUG-CSF (G-CSF) given every 2 weeks and compared the dose-intensity achieved with this schedule with that obtained in a previous study we conducted in which the same regimen was given every 3 weeks without G-SCF (EC 21). The secondary objective was to explore the activity of this regimen. PATIENTS AND METHODS: Between December 1991 and March 1994, 41 patients (pts), 19 with locally advanced breast cancer (LABC) and 22 with metastatic breast cancer (MBC), were given high-dose epirubicin (Hd-Epi) (120 mg/m2) and cyclophosphamide (CTX) (600 mg/m2) on day 1 every 14 days (EC 14) plus granulocyte colony-stimulating factor (G-CSF) (5 mcg/kg/d s.c. on days 2-12). A total of 8 cycles in LABC pts (4 pre- and post-surgery), and 6-8 cycles in MCB pts were administered. The results were compared with those obtained in the previous study. RESULTS: The incidence of WHO grade 3-4 neutropenia was significantly reduced in the EC 14 + G-CSF regimen (25.2% vs. 46.8% in 214 and 250 evaluable cycles, respectively, p<0.0001), as well as the incidence of neutropenic fever (7% vs. 3%, p=0.05). Grade 3-4 anemia (36.6% vs. 8% pts, p=0.001) and grade 3-4 thrombocytopenia (17.1% vs. 0 pts, p=0.002), were significantly more frequent in EC 14 + G-CSF. No significant differences in the other side effects were found. A total of 17 of 207 of the cycles (8.2%) were delayed in the EC 14 + G-CSF vs. 58/271 (21.4%) in the EC 21 (p<0.0001). The main reasons for these treatment delays were neutropenia (1% vs. 15%), anemia (3% vs. 0) and thrombocytopenia (1% vs. 0). As a result of treatment acceleration and differences in dose delays, the patients on EC 14 + G-CSF received a higher dose-intensity (Epi 58.51 mg/m2/wk vs. 36.8 mg/m2/wk; CTX 292.52 mg/m2/wk vs. 182.9 mg/m2/wk). A complete response at surgery was obtained in 9/19 (47.4%) LABC pts. An objective CR was obtained in 11/22 MBC pts (50%) and a partial response in 8/22 (36.4%), yielding an overall response rate of 86.4%. CONCLUSIONS: Hd-Epi + CTX is very active against both LABC and MBC. The administration of G-CSF allows dose intensification of both drugs (a 59.5% increase of the actual dose intensity) with acceptable clinical tolerance (a lower incidence of neutropenia but a higher incidence of anemia and thrombocytopenia). Only a specifically designed phase III trial will lead to definitive conclusions regarding the greater antitumor activity of accelerated CSF-including regimens as compared to standard chemotherapy for advanced breast cancer.

Adult↗
PubMed1995

DNA ploidy, proliferative index, and epidermal growth factor receptor: expression and prognosis in patients with gastric cancers.

BACKGROUND: The 5-year survival rate of patients with stomach cancer is usually around 20%. The clinico-pathological features that are presently used to assess patient prognosis are not sufficient to define gastric tumor behavior. Therefore, an accurate analysis of different biological characteristics of gastric cancer cells could allow the course of disease to be predicted and may help to improve treatment strategies. EXPERIMENTAL DESIGN: The prognostic values of DNA ploidy, proliferative activity and epidermal growth factor receptor (EGF-R) expression were studied in gastric tumors from a series of 63 patients. DNA ploidy and proliferative activity, evaluated in terms of DNA index (DI) and proliferative index (PI), respectively, were determined by flow cytometry on paraffin-embedded tumor tissues. EGF-R expression was detected by immunohistochemistry on paraffin-embedded tumor sections of the same specimens. The clinico-pathological and the biological parameters were then correlated, and the patients overall survival was calculated using a chi-square test and the Kaplan-Meier method. RESULTS: DNA ploidy abnormal cell clones were found in 44% of cases (median DI = 1.4, range 1.04-2.5). Aneuploid tumors showed high PI more frequently than diploids (71% versus 36%, p = 0.01). The analysis of the expression of EGF-R revealed that 88% of aneuploid tumors were positive for receptor expression. On the contrary, diploid tumors showed the presence of EGF-R only in 56% of cases (p = 0.01). DI, PI, and EGF-R expression were not related to histological grade. Conversely, the three biological parameters were significantly correlated to clinical stage and tumor invasion. The Kaplan-Meier survival curves showed a 73% 5-year survival rate in patients with diploid tumors whereas only 33% of patients with aneuploid lesions had a good prognosis (p = 0.001). CONCLUSIONS: We demonstrate that DNA ploidy, PI, and EGF-R expression are closely related to some pathological and clinical characteristics in gastric cancer. The close relationship between aneuploidy, EGF-R positive expression, node involvement, and tumor invasion suggests that these parameters may be indicators of high malignancy. Finally, the results also show that aneuploidy and EGF-R-positive expression are indicative of a worse prognosis in gastric cancer patients. The study of these parameters might allow a more accurate stratification of patients, so that a targeted therapeutic protocol may be defined.

Aged↗
PubMed1995

Personality, inner experience and compliance in advanced cancer patients treated with external pumps.

The presence of portable pumps for protracted infusional chemotherapy in metastatic solid tumors at an advanced stage determines the need to evaluate psychologically the inner experience of the patients in relation to this therapeutic modality. The objective of the study were to analyze personality variables (coping and awareness), inner experience variables (acceptance and expectations) and the compliance of the patients during repeated courses of therapy. In addition we evaluated the influence of sex, age, level of education and response to treatment in relation to these variables. From February 1992 to March 1994 we evaluated 50 metastatic patients with a psycho-dynamic interview at the 1st, 3rd, 6th and the 9th course of therapy. The data obtained showed a positive trend for all the variables examined and in all the subgroups (age, sex, level of education, response) up to the 6th course. After the 6th course, personality variables remained stable, yet a drop in variables related to inner experience and compliance was observed in the whole group. While the personality variables remain constant in all patients, a decrease of acceptance and expectation was observed in patients non responding to therapy for their tumor, a trend which becomes significative at the 9th course regards expectation. The use of a psycho-dynamic interview allowed us to evaluate the effect of treatment on psychological variables and compliance to therapy. The length of treatment and the response to treatment seem to influence the more profound inner experiences of the patients.

Adaptation, Psychological↗
PubMed1995

Evaluation of the response to chemotherapy in patients affected with small cell lung cancer using discriminant analysis: a preliminary report.

This report represents an attempt to combine the serum levels of more tumor markers together to evaluate the response to chemotherapy in 26 patients affected with small cell lung cancer (SCLC), by means of discriminant analysis. A pilot prospective study was performed on 26 subjects affected with inoperable SCLC (18 extensive diseases, and 8 limited diseases) and treated with chemotherapy (etoposide plus cisplatin regimen). Serum levels of a panel of tumor markers: Carcinoembryonic antigen (CEA), Tissue Polypeptide Antigen (TPA), Neuron Specific Enolase (NSE) and CYFRA -21.1 were determined before starting chemotherapy and at the restaging time (after 3 months). To optimize the classification power of these markers, a discriminant analysis was done, which permitted generating two classification functions, based on Tissue Polypeptide Antigen and Neuron Specific Enolase levels able to correctly classify 25 out of 26 subjects (8 progressions and 18 non progressions). The results obtained, furtherly confirm that tumor markers are useful to evaluate the chemotherapy response and indicate a possible approach to obtain the maximum usefulness of the serum marker levels.

Adult↗
PubMed1994

Improved local control and survival with the "sandwich" technique of pelvic radiotherapy for resectable rectal cancer. A retrospective, multivariate analysis.

PURPOSE: The following study was done to evaluate the therapeutic value of radiotherapy as an adjunct to surgery for rectal cancer patients. METHODS: One-hundred twenty-four patients underwent curative resection by one surgeon (RC) from 1982 to 1991. Forty patients received combined preoperative and postoperative (sandwich) radiotherapy, 30 patients received postoperative radiotherapy, and 54 patients were treated by surgery alone. During the study period sandwich radiotherapy was primarily offered as a free treatment option for patients with tumors which were believed to be transmurally invasive, whereas postoperative radiotherapy was an alternative therapeutic option offered to patients with tumor classified as Dukes B and C at histopathologic examination. RESULTS: Operative mortality was 2 percent in the sandwich radiotherapy group vs. 7 percent in the surgery alone group. After a median follow-up of 60 months, the actuarial locoregional recurrence rate at five years was 3 percent for the sandwich radiotherapy group compared with 18 and 30 percent for the postoperative radiotherapy and surgery alone groups, respectively (P = 0.019). A multivariate analysis using the Cox model confirmed the favorable independent influence of sandwich radiotherapy on local tumor control, especially in distal tumors. The therapeutic benefit of sandwich radiotherapy translated into increased survival in the low-rectum Dukes B subgroup of patients. The actuarial five-year survival rates were 86 percent, 50 percent, and 28 percent in the sandwich radiotherapy, postoperative radiotherapy and surgery alone groups, respectively (P = 0.05). CONCLUSIONS: Preoperative radiotherapy has a significant effect on the prognosis of rectal cancer patients.

Adult↗
PubMed1994

Nerve-sparing surgery in 302 resectable rectosigmoid cancer patients: genitourinary morbidity and 10-year survival.

PURPOSE: The aim of this study was to evaluate 5-year and 10-year disease-free survival, urinary dysfunction, and sexual activity after nerve-sparing radical surgery, including lumboaortic lymphadenectomy for rectosigmoid cancer. METHODS: Since 1980 to 1992, 302 consecutive patients affected with rectal (188) or sigmoid (114) resectable cancer underwent radical surgery. Lumboaortic lymphadenectomy was routinely performed and total mesorectal dissection was always accomplished in rectal cancer. Splanchnic nerves, superior hypogastric plexus, hypogastric nerves, and sacral parasympathetic nerves were sought, identified, and preserved or, when necessary, unilaterally sacrificed. Fifty-three (17.6 percent) patients were classified Dukes A, 145 (48.0 percent) B, 46 (15.2 percent) C1, and 17 (5.6 percent) C2. Thirty-nine (12.9 percent) patients were Dukes D. In 85 rectal cancer patients, tumor was located at the lower third. Eighty-six of 210 Dukes B and C patients were submitted to systemic chemotherapy and/or high-dose pelvic radiotherapy. RESULTS: The actuarial 5-year disease-free survival was 58.5 percent in rectal and 65.7 percent in sigmoid cancer patients, median follow-up time was 47 months. During the follow-up, each patient was interviewed about sexual activity and urinary dysfunction and a questionnaire was filled out. Urinary dysfunction was not frequently observed, while a definitive sexual impotence was reported in 27.6 percent of the patients. The age under 60 years and sphincter-saving surgery were demonstrated as significantly contributing to retaining a satisfactory sexual activity. CONCLUSIONS: Unexpectedly high disease-free survival was observed in the Dukes C2 subgroup. It allows us to hypothesize that lumboaortic lymphadenectomy could remove neoplastic microfoci present at this level in those patients, enhancing surgical chances of cure. The majority of male patients under 60 years old can retain a satisfactory sexual activity after undergoing a nerve-sparing sphincter-saving cancer surgery.

Adult↗
PubMed1994

Randomised phase II study of methotrexate (MTX) versus methotrexate plus lonidamine (MTX + LND) in recurrent and/or metastatic carcinoma of the head and neck.

Between March 1990 and March 1992, 89 patients with recurrent and/or metastatic squamous cell cancer of the head and neck were randomised to receive either intravenous methotrexate (MTX) at a weekly dose of 40 mg/m2 plus lonidamine (LND) given orally at a starting dose of 75 mg three times daily for 3 days and then at a dose of 150 mg three times daily (arm MTX + LND) or methotrexate alone (arm MTX) at the same doses as arm MTX + LND. Complete remissions were observed in 10.5% of the patients in arm MTX + LND, and partial remissions in another 15.8%, yielding a 26.3% response rate. In arm MTX, only partial remissions were observed, yielding an overall response rate of 18.2%. Haematological toxicity was mild in both groups. Mild testicular pain (21%) and myalgias (31%) occurred only in patients treated with LND.

Adult↗