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PURPOSE: Based on in vitro and on clinical evidence of protection against acute side effects of radiation, a prospective randomized, open study was performed to determine the efficacy of an oral proteolytic enzyme preparation in patients with head and neck cancer receiving conventional fractionated radiation therapy. METHODS: Patients with stage T3/T4 head and neck cancer were eligible. One hundred patients from two centres were entered into the study. 60Co gamma-radiation was delivered at a standard daily radiation dose of 2 Gy in 25-35 fractions over a period of 6-7 weeks. Two lateral parallel opposing fields were used with a portal area of 10 x 15 cm. Patients assigned to the test group arm additionally received enzyme tablets orally t.i.d. starting 3 days prior to radiation therapy, and continuing up to 5 days after completion of the course of radiation therapy. Patients in the control arm were not given any drug or placebo. Acute radiation side effects were described as mucositis, skin reaction, dysphagia, and were graded at each visit during and after radiation therapy, following RTOG/EORTC criteria. RESULTS: The severity (maximum extent) of acute radiation therapy side effects was significantly less in enzyme-treated patients than in control patients: mucositis (mean: 1.3 vs 2.2, P < 0.001), skin reaction (1.2 vs 2.4, P < 0.001) and dysphagia (1.4 vs 2.2, P < 0.001). The duration of these side effects as well as the sum scores of side effects were also less in the study arm. CONCLUSIONS: Combination of enzyme therapy with conventional fractionated radiation therapy was feasible and well-tolerated. There was significant protection against acute side effects of radiation therapy in the study arm. Not only was the severity of acute side effects less but the duration was shorter and the time to onset was also delayed. Prospective randomized double-blind studies would verify this role of an oral enzyme therapy as standard co-medication with radiation therapy to the head and neck region.

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Differentiated carcinoma of the thyroid has good prognosis, even in patients presenting in the late stage and with distant metastasis. In India, the incidence of papillary carcinoma and follicular carcinoma are in the ratio of 60∶40. A retrospective study was carried out to determine the impact of patient and tumor factors on survival, and to develop a simple rish group staging system to predict survival in patients with differentiated thyroid carcinomas. Four hundred and seventeen (417) patients undergoing primary treatment at our hospital between 197-1985, were entered to the study. There were 198 follicular carcinomas and 219 papillary carcinomas. Impact of patient and tumor variables were studied by drawing Kaplan Meier curves and comparing them by the Chi Sq Test. Age<=40 years (p=0.00001), tumor size <5cms (p=0.01), extrrathyroidal spread (p=0.001) and distant metastasis (p=0.00001) had significant impact on survival. These finding were true for a subset analysis follicular and papillary carcinomas separately. A Cox Regression Analysis was also performed and this showed the above factors to impact significantly on survival. Basing on the regression analysis we devised a simple risk group system and classified the patients as high and low risk. Low risk group patients had a significant survival advantage. Our findings show that the incidence of follicular carcinoma is significantly high in india (48%) and that 65% of our patients are in the high risk group. Incidence of contralateral lobe disease on completion thyroidectomy is as high as 53%. Hence, a more aggressive treatment policy is warranted and total thyroidectomy is the appropriate treatment of choice in our patients.

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Cancer of the oral tongue is a common disease. Thirty five (35%) percent of patients seen at our hospital are in Stages I&II. The choice of surgical treatment is a wide excision of the lesion (WE) or a hemiglossectomy (HG). This study was carried out to compare the local recu-rrences and survival in patients undergoing either a WE or HG for early cancer of the tongue. One hundred and twenty six (126) patients were evaluated, 40 underwent a WE and 86 HG. The local recurrence was higher in the WE group, 25% compared with 9% in the HG group; which is statistically significant (p=0.02). This was also seen in the Tl subgroup (p=0.003). Survival were better in the HG group (p=0.005), which was also seen for the Tl subgroup (p=0.004). Our study demonstrates that there is a lower incidence of local recurrences following a hemiglossectomy for Tl-2 tumours of the oral tongue with improved survivals. Our recommendation is that hemi-glossectomy should be the optimal surgery performed for early cancer of the oral tongue.

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One hundred and sixty five patients, treated with carbondioxide (CO2) laser for benign and malignant lesions of the head and neck were studied. Alveolo-buccal complex (68/165) had the majority of benign and malignant tumors followed by larynx (23/165) and tongue (21/165). All lesions were widely excised, none were reconstructed and all defects healed well with minimal scarring. The post-operative morbidity was minimal and the hospitalization period was 1 to 5 days. Complications were not serious and could be managed easily. This study confirms the usefulness of CO2 laser surgery for both benign and malignant conditions in head and neck.

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A retrospective analysis of 127 surgically treated cases of T-1, T-2 carcinoma of oral tongue during the period 1987-1990 was undertaken. 68.5 per cent (87) underwent hemiglossectomy and 31.5 per cent (40) underwent wide excision. There were loco-regional recurrences in 22 per cent (27). In the hemiglossectomy group 9 per cent (8 of 87) had local recurrences compared to 25 per cent (10 of 40) of wide excision group, (P = 0.01). Mean disease free survival was 40 months and 33 months for hemiglossectomy group and wide excision group respectively, (P = 0.006). It is seen that local recurrences are significantly less for the hemiglossectomy group compared to the wide excision group.

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BACKGROUND: It was observed that new presentations of anaplastic carcinoma of the thyroid had become infrequent in the last two decades. METHODS: All cases of thyroid cancer seen at our centre between 1969-1993 (n = 2921) were classified as papillary 49%, follicular 34%, medullary 7.5%, anaplastic 4.7%, and other 4.8%. The total number of thyroid cancers show a 3.5-fold rise. RESULTS: The differentiated thyroid cancers show a significant rising trend as against the relative proportion of anaplastic carcinoma, which shows a significant decline (P = 0.002). Clinicopathologic data on 124 patients of anaplastic carcinoma revealed 50% patients had either long-standing goitres, previous thyroid abnormalities, or associated differentiated thyroid carcinoma on histology. CONCLUSIONS: The decline in the relative proportion of anaplastic carcinoma may in part be explained by the clinicopathologic findings or it may be attributed to histological reclassification.

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OBJECTIVE: In this report, we evaluate the recurrence- and progression-free survival of patients with meningiomas involving the cavernous sinus. METHODS: The rates of tumor recurrence and progression in 119 patients with meningiomas involving the cavernous sinus treated between 1983 and 1993 were analyzed. RESULTS: The mean follow-up period was 33.8 months. There were seven recurrences of completely resected tumors (7 of 73, 10%) and seven progressions of incompletely resected tumors (7 of 46 15%). Life table analysis of recurrence- and progression-free survival was performed. The recurrence-free survival rate was 94% at 3 years and 81% at 5 years. In contrast, the progression-free survival rate was 87% at 3 years and 62% at 5 years (P = 0.0456). There were two patterns of recurrence or progression. The first group of tumors had an aggressive biological behavior with growth at multiple areas of resection; the second group showed growth at or near the margins of resection. Functional status continued to improve slowly during the follow-up period; however, there was no statistically significant difference between the Karnofsky scores obtained 3 to 12 months postoperatively and the follow-up Karnofsky scores (obtained > 1 yr postoperatively). CONCLUSION: Surgery for meningiomas involving the cavernous sinus seems to provide excellent tumor control. Our experience suggests that for the majority of these tumors, complete tumor resection can be performed with acceptable risks of morbidity and mortality and seems to increase the duration of recurrence-free survival. The long-term quality of life of surviving patients is satisfactory, with the great majority of the patients being independent.

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BACKGROUND: Prognostic parameters for papillary carcinoma of the thyroid have been defined by several groups. However, no such study has been reported for follicular carcinoma. METHODS: We undertook a retrospective study of well-differentiated carcinoma of the thyroid operated at the Tata Memorial Hospital during the period 1970-1985. In our series, follicular carcinoma formed 48% of the well-differentiated carcinomas of the thyroid. The variables age, sex, size, extrathyroidal spread, distant metastases, and lymph node metastases were evaluated. The survival was plotted according to the Kaplan-Meier method, and graphs compared by log-rank test. Univariate and multivariate analyses were performed. RESULTS: Based on our experience we stratified the cases into low-risk and high-risk groups. The low-risk group included: age below 40 years, tumor size less than 5 cm. and no extrathyroidal extension or metastases. This low risk group had 100% survival at 15 years, compared with 40% survival for the high-risk group (P <.001). Seventy-three percent (73%) of our cases were in the high-risk group. CONCLUSIONS: Based on our findings that the majority of our patients were in the high-risk group, we advocate a total or near-total thyroidectomy in treatment of follicular carcinoma of the thyroid. There is a need to arrive at a universally acceptable classification of risk groups in follicular carcinoma of the thyroid gland.

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Cosmetic disfigurement and loss of voice following a total laryngectomy can cause major psychosocial problems. Fifty patients who had undergone a total laryngectomy and completed more than six months following surgery, were randomly selected during a routine follow-up, and asked to answer a questionnaire, to asses their degree of disability and extent of rehabilitation. The questionnaire have five main components viz. general information, functional evaluation, vocal rehabilitation, social assessment and economic sequelae. Results revealed that these patients suffered from a significant decrease in social acceptance (70%), social activity (82%), sexual activity (62%), ability to communicate vocally (58%), and severe financial repercussions (78%). A large number of patients (40%) were dissatisfied with the present level of rehabilitation offered. Inspite of these problems the majority (80%) were willing to accept a total laryngectomy as treatment of their cancer. This emphasizes the need for greater interaction between the treating surgeon, speech therapist, occupational therapist, and psychotherapist to rehabilitate these patients adequately.

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BACKGROUND: Cancer of the alveolo-buccal complex even when locally advanced is amenable to curative resection. However, the extent of lymph node dissection remains controversial. METHODS: A total of 181 patients with T3/T4 cancer of the alveolo-buccal complex who underwent a radical neck dissection (RND) were analyzed retrospectively to determine the incidence and pattern of lymph node involvement and to define the extent of neck dissection required in these cancers. RESULTS: Lymph node involvement was as follows: level I (85%), II (51%), III (19%), IV (18%), V (5%). Levels I and II were most commonly involved (94%). Skip metastases occurred in 13%. Levels IV and V were involved in 2% and 20% when levels I, II, and III were uninvolved and involved, respectively. CONCLUSION: A supraomohyoid neck dissection (SOHD) should be performed and subjected to a frozen section evaluation in every patient. If lymph nodes are negative, then SOHD is adequate. If levels I, II, or III are positive, then a RND should be performed.

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In the final report of a prospective, randomized controlled clinical trial, we report the results of using adjuvant perioperative chemotherapy in patients with oral cancer. Our study is based on the hypothesis of Goldie and Coldman. A total of 135 patients with alveolobuccal carcinoma, classified as clinically stage III and IV, were entered on the protocol. After a curative resection, they were randomized. The patients in the test arm of the study received methotrexate 50 mg/m2 on the 3rd, 10th, and 17th postoperative days. The patients in the control arm underwent observation. This analysis at 24 months showed a disease-free survival rate of 61% in the test arm versus 37% in the control arm, which is statistically highly significant (P < 0.01). Analysis of the recurrence pattern showed that recurrence at the primary site was dramatically reduced during the first 6 postoperative months (P = 0.002). Our study provided further clinical evidence in support of the concepts of Goldie and Coldman that the timing of chemotherapeutic drugs is critical for a successful end result.

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Tracheal rupture occurred in 7 of 174 (4%) patients undergoing laryngopharyngectomy with gastric transposition. Tracheal tears were classified as proximal if they involved the upper two-thirds of the trachea (five patients), or distal if they extended into the lower one-third of the trachea (two patients) and their clinical features and management analyzed. Predisposing factors, including prior radiotherapy (three patients) and preoperative tracheostomy (1 patient) did not influence the site or severity of tracheal injury. Proximal tears were detected incidentally in four patients, but in one patient, manifested postoperatively with subcutaneous emphysema and pneumothorax. Distal tears manifested dramatically with a ventilatory leak. Adequate access for repair of distal tears may necessitate a right thoracotomy while proximal tears may be sutured through the cervical incision. Gastric transposition alone did not prevent air leak in two patients. Postoperative complications included prolapse of the stomach and bilateral pneumothoraces in one patient. Close interaction between the surgeon and the anesthesiologist ensured a successful outcome in six patients. There was one mortality.

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Primary adenocarcinoma of the esophagus is uncommon and the incidence in the middle third of the esophagus is rare, accounting for about 0.7%-1.5% of cases. Metastasis of carcinoma to the eye is a rare occurrence. We report here a case of primary adenocarcinoma of the middle third of the esophagus with choroidal metastasis.

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The dilemma of increasing costs of medical care and shrinking health budgets has stimulated attempts to implement stricter control on expenditure without affecting the quality of care. This study shows that in patients with operable breast cancer, a policy of early discharge after a mastectomy did not have deleterious effects on wound healing and was well accepted by patients. In a randomized trial, drains were removed after either 3 or 6 days postmastectomy, and in both groups of patients there was no difference between the mean volumes of seromas aspirated or the number of aspirations and return visits to the hospital. This suggests that a policy of early discharge is safe, acceptable, economical, and may improve bed utilization.

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Primary adenocarcinoma of the esophagus is uncommon and the incidence in the middle third is rare, accounting for about 0.7 percent to 1.5 percent. Metastasis of carcinoma to the eye is a rare occurrence. We report here a case of primary adenocarcinoma of the middle third of the esophagus with choroidal metastasis.

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Esophageal diverticula are rarely found at the terminal portion, where they are called supradiaphragmatic or epiphrenic diverticula and occur in association with motility disorders of the terminal esophagus. We present here two cases of epiphrenic esophageal diverticulum, one of which was treated surgically.

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Malignant mixed salivary tumors are rare, accounting for 2%-10% of all mixed salivary tumors. Rarer still are metastasis from a malignant mixed salivary tumor. A case of malignant mixed salivary tumor occurring in the parotid gland and presenting as a parapharyngeal mass; with asymptomatic multiple bony metastasis is presented with a brief review of literature.

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This is an interim report of a study of perioperative adjuvant chemotherapy following radical surgery for oral cancer, based on the hypothesis of Goldie and Coleman. 135 patients of alveolobuccal carcinoma, clinically stage III and IV, were entered on the protocol. After a curative resection, they were randomized. The test arm received methotrexate 50 mg/m2 on the 3rd, 10th, and 17th postoperative days. The control arm was only observed. This analysis at 12 months showed a disease free survival of 71% in the test arm vs. 45% in the control arm, which is statistically highly significant (P less than 0.01). Analysis of recurrence pattern showed that recurrence at the primary site was dramatically reduced during the first 6 postoperative months (P less than 0.01). Our study provided further clinical evidence in support of the concepts of Goldie and Coleman that the timing of chemotherapeutic drugs is very critical for a successful end result.

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Diverticula of the gall bladder are very rare. We present here a patient with a giant diverticulum of the gall bladder with features of cholecystitis and cholelithiasis.

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